# Sofwave in Seoul > Sofwave is a non-invasive ultrasound skin-tightening device that heats the mid-dermis with seven parallel, non-focused beams. The guides cover how it works, its US FDA clearances, who it suits, recovery, the published studies and what a session costs in Seoul. ## Sofwave in Seoul: how the device works and what the evidence shows Source: https://sofwave-seoul.com/ Updated: 2026-10-24 **Sofwave** is a non-invasive skin-tightening device built on SUPERB (Synchronous Ultrasound Parallel Beam) technology and made by Sofwave Medical Ltd. Seven transducers fire together, delivering high-frequency, non-focused ultrasound to a fixed depth of about 1.5 mm in the mid-dermis, while contact cooling protects the surface. The US FDA cleared the system for eyebrow, submental and neck lifting on 15 November 2021 under K211483. - Depth: At a target treatment depth of about 1.5 mm, in the mid-dermis, with thermal zones spanning roughly 0.5 to 2 mm. - Sessions: The number of sessions depends on the treatment area and plan. The upper-arm study in K233104 used two sessions, 1–3 weeks apart. Ask your clinician to explain the proposed schedule and when your response will be assessed. - Recovery: Most people resume usual activity the same day and there is no dressing or scheduled recovery. Mild redness or tenderness on pressure may persist for a day or two. ### FAQ ### How long does a Sofwave session take? Published reports describe sessions of roughly 30 to 60 minutes depending on how many areas are treated. That is the treatment itself; allow additional time for check-in, consultation and topical anesthetic. ### When will I see a result? Early tightness may reflect transient tissue responses, including thermal contraction and swelling. Assess sustained improvement over subsequent months. The measurable change develops over weeks to months as new collagen forms; studies found significant change at one and three months, with the two-to-three-month visit the meaningful assessment point. ### How long do the results last? Some clinical studies followed outcomes for six months; an acne-scar case series followed patients for up to eight months. A separate biopsy study documented tissue remodeling for up to ten months. Figure: Seven evenly spaced vertical bars descending in parallel and stopping together at one shared horizontal band Seven parallel beams with a target treatment depth of about 1.5 mm. ### Sofwave in one paragraph Sofwave is a non-invasive ultrasound device made by Sofwave Medical Ltd. Microfocused ultrasound concentrates energy into small points at selectable depths. Sofwave’s seven synchronized, non-focused ultrasound beams create separate cylindrical thermal zones in the dermis, centered approximately 1.5 mm deep. The published clinical reports place the frequency at 10–12 MHz and the treated zone at roughly 60–70 °C, which is the range associated with controlled collagen denaturation and the wound-healing response that follows. The epidermis is protected by contact cooling and a real-time skin-temperature monitor rather than by aiming the energy around it. Full device parameters are on the [What is Sofwave](https://sofwave-seoul.com/what-is-sofwave/) page. Figure: Street-level view of the Gangnam district of Seoul Gangnam, Seoul. ### How to choose a Sofwave clinic in Seoul When comparing Sofwave clinics in Seoul, check the treating clinician, device, written quote and follow-up arrangements. - **Who will assess and treat you?** Confirm the clinician's role and specialist credentials. See [Delight Dermatology Clinic’s credential information](https://hifuseoul.com/credentials/). - **Which device and treatment areas are proposed?** Ask for the exact device name, confirmation of its authenticity and the planned areas. The [Sofwave device guide](https://sofwave-seoul.com/what-is-sofwave/) and [Sofwave vs Ultherapy comparison](https://sofwave-seoul.com/sofwave-vs-ultherapy/) explain the equipment differences to discuss. - **What does the written quote cover?** Confirm the treatment areas, whether the amount is per session, and which consultation, comfort or follow-up services are included or charged separately. See [Sofwave prices in Seoul](https://sofwave-seoul.com/pricing-seoul/). - **How will you communicate before and after the visit?** Confirm language support for your appointment and how to contact the clinic after returning home. The [international-patient information at Delight Dermatology](https://hifuseoul.com/for-international-patients/) covers visit preparation and consultation fees. ### What a consultation looks like International patients can start with a general enquiry and no photograph. If you choose a photo-based preliminary review, you may optionally share a no-makeup front and side photograph and relevant prior treatment history. That can support an initial discussion, but the in-person examination is what confirms candidacy, the treatment areas, the pulse count and the final plan. Allow roughly 30 to 60 minutes for the treatment itself, depending on how many areas are included. ### Where Sofwave fits, and where it does not Sofwave suits mild to moderate laxity and textural change in people who want a non-invasive, low-downtime treatment and are willing to wait months for the result to develop. Session schedules depend on the indication and protocol; the FDA K233104 upper-arm study used two sessions 1–3 weeks apart. It does not substitute for a surgical lift when laxity is advanced, it does not remove fat, and it does not erase deep static folds. Where the laxity is deeper than the mid-dermis, microfocused ultrasound or a surgical consultation may be more suitable. See the [comparison page](https://sofwave-seoul.com/sofwave-vs-ultherapy/) and the [candidacy guide](https://sofwave-seoul.com/candidates-and-contraindications/) for screening criteria. ### Published references 1. Hongcharu W, Boonchoo K, Gold MH. The efficacy and safety of the high-intensity parallel beam ultrasound device at the depth of 1.5 mm for skin tightening. *Journal of Cosmetic Dermatology*. 2023;22(5):1488–1494. [PubMed](https://pubmed.ncbi.nlm.nih.gov/36757157/) · doi:10.1111/jocd.15672 2. Gold MH, Biron J. Efficacy and safety of high-intensity, high-frequency, non-focused ultrasound parallel beams for facial skin laxity. *Journal of Cosmetic Dermatology*. 2024;23(1):117–123. [PubMed](https://pubmed.ncbi.nlm.nih.gov/38031530/) · doi:10.1111/jocd.16098 3. Liao D, Prasad A, Bloom JD. Use of ultrasound in face and neck rejuvenation. *Facial Plastic Surgery*. 2026 (online ahead of print). [PubMed](https://pubmed.ncbi.nlm.nih.gov/41985490/) · doi:10.1055/a-2854-6601 ## About the medical reviewer Source: https://sofwave-seoul.com/about-the-clinician/ Updated: 2026-10-24 **The medical reviewer is a Korean Board-Certified Dermatologist.** ### Credentials **Korean Board-Certified Dermatologist.** Specialist board certification recognized by the Ministry of Health and Welfare, Republic of Korea. In Korea this is a distinct qualification from a general medical license, and it is the one worth checking when comparing clinics. ### Comparison evidence A small randomized split-body trial compared Sofwave and Ultherapy for upper-inner-arm laxity. Its findings should not be generalized to facial or neck treatment. [Loyal et al.](https://pubmed.ncbi.nlm.nih.gov/41025649/) ### Individual assessment Candidacy, treatment areas and pulse count are determined at an in-person examination. ## Sofwave aftercare and downtime Source: https://sofwave-seoul.com/aftercare-downtime/ Updated: 2026-10-18 Sofwave downtime and result assessment follow different timelines. Plan activity and skincare around your skin’s response and the treating clinician’s instructions. ### Reported short-term effects [Gold and Biron’s study](https://doi.org/10.1111/jocd.16098) followed 15 women aged 40–69 through two sessions and visits three and six months after the last treatment. Mild redness and swelling resolved spontaneously; one case of mild facial peeling settled within three days. No serious adverse events were observed during that study. The authors reported that all participants could resume normal activities after treatment. ### Recovery versus result assessment ### Follow-up periods in published studies 1. [3 and 6 months](https://doi.org/10.1111/jocd.16098) Clinical facial-laxity assessments after the final session in a 15-participant study. 2. [Up to 8 months](https://doi.org/10.1111/jocd.70134) Acne-scar case series: follow-up varied, averaging 3.6 months. 3. [Up to 10 months](https://pubmed.ncbi.nlm.nih.gov/41405933/) Serial biopsies documented tissue remodeling. Recovery and follow-up after Sofwave | Time after treatment | Reported findings or assessment | | --- | --- | | Immediate responses | Gold/Biron: mild redness and swelling resolved spontaneously in the 15-participant study. | | Day 1–3 | Gold/Biron: one case of mild facial peeling resolved within three days. | | Month 1 | A clinical study assessed changes in facial-fold volume at one month. | | Month 2–3 | A biopsy study assessed dermal collagen and elastin at two months; clinical studies assessed outcomes at three months. | | After the initial course | The need and timing for maintenance treatment depend on examination and the treatment response. | ### Individual aftercare instructions Confirm when to resume makeup, exercise, retinoids and exfoliating products with the treating clinician. Use gentle skincare and sun protection, and agree on the timing of any further treatment in the same area. Contact the treating clinic for worsening redness or swelling, blistering, crusting, new numbness, asymmetry of facial movement or fever. For local procedure details, see [Sofwave information in Seoul](https://hifuseoul.com/procedures/sofwave-seoul/). ### How the result develops Histology work on this device describes thermal injury confined to the dermis followed by a gradual increase in collagen and elastic fiber density, measurable at two months in one Korean study and continuing across a ten-month follow-up in another. Imaging-based studies measured tissue contraction of about 1.9 mm at eight weeks, essentially unchanged at 24 weeks, and fold-depression volume reductions that were significant at one and three months with no significant further change between those visits. Some clinical studies followed outcomes for six months; an acne-scar case series followed patients for up to eight months. A separate biopsy study documented tissue remodeling for up to ten months. ### Maintenance after the initial course Initial session counts and intervals depend on the indication and protocol. The [FDA K233104 upper-arm study](https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233104.pdf) used two sessions 1–3 weeks apart. After completion of the initial course, further or maintenance treatment is considered separately at reassessment. ### Published references 1. Hongcharu W, Boonchoo K, Gold MH. The efficacy and safety of the high-intensity parallel beam ultrasound device at the depth of 1.5 mm for skin tightening. *Journal of Cosmetic Dermatology*. 2023;22(5):1488–1494. [PubMed](https://pubmed.ncbi.nlm.nih.gov/36757157/) · doi:10.1111/jocd.15672 2. Gold MH, Biron J. Efficacy and safety of high-intensity, high-frequency, non-focused ultrasound parallel beams for facial skin laxity. *Journal of Cosmetic Dermatology*. 2024;23(1):117–123. [PubMed](https://pubmed.ncbi.nlm.nih.gov/38031530/) · doi:10.1111/jocd.16098 3. Suh DH, Lee SJ, Song KY, Ahn HJ, Shin MK. High-intensity, parallel ultrasound tightening of facial skin: clinical and pathologic results. *Journal of Cosmetic Dermatology*. 2025;24(2):e16670. [PubMed](https://pubmed.ncbi.nlm.nih.gov/39530193/) · doi:10.1111/jocd.16670 4. Boonchoo K, Hongcharu W. The efficacy and safety of a single treatment of high-intensity, high-frequency, non-focused ultrasound parallel beams for facial acne scars in Asian patients: a preliminary study. *Journal of Cosmetic Dermatology*. 2025;24(4):e70134. [PubMed](https://pubmed.ncbi.nlm.nih.gov/40132902/) · doi:10.1111/jocd.70134 5. Carruthers J, Benitez Roig V, McDaniel DH, Jackson B, Bedich O, Amir R, Eckhouse S. Synchronous parallel ultrasound induces long-term extracellular matrix remodeling of human skin. *Dermatologic Surgery*. 2025;51(9S):S58–S64. [PubMed](https://pubmed.ncbi.nlm.nih.gov/41405933/) · doi:10.1097/DSS.0000000000004793 · Author group includes employees of the device manufacturer. 6. Oku K. Vectorized facial skin tightening: a study on the Thermal Thread Technique utilizing high-intensity, high-frequency, parallel ultrasound beam. *Lasers in Surgery and Medicine*. 2024;56(4):355–360. [PubMed](https://pubmed.ncbi.nlm.nih.gov/38411259/) · doi:10.1002/lsm.23771 ## Who Sofwave suits, and who it does not Source: https://sofwave-seoul.com/candidates-and-contraindications/ Updated: 2026-10-18 **Sofwave suits adults with mild to moderate skin laxity and textural change who want a non-invasive, low-downtime option and can wait months for the result to develop.** Session schedules depend on the indication: the FDA K233104 upper-arm study used two sessions 1–3 weeks apart. It suits people whose problem is dermal: crepey texture, loss of firmness along the jawline and neck, early submental laxity, fine lines. It does not suit people whose laxity is advanced enough that a surgical lift is the honest answer, people expecting fat reduction, or people who need a visible result by a fixed date. Screening at examination covers pregnancy, active infection or open lesions in the treatment area, recent injectables or threads in the area, keloid history, uncontrolled systemic illness and implanted devices. The decisive list is the manufacturer's instructions for use combined with the treating clinician's assessment. Figure: An orderly grid of rounded tiles with three tiles lifted out and set aside Screening identifies who is suitable for treatment. ### Reasonable candidates - **Mild to moderate dermal laxity.** The published series enrolled patients with mild-to-moderate laxity, typically from their thirties into their sixties, and that is the population the evidence actually describes. - **Textural change rather than volume loss.** Crepey skin, loss of firmness, fine lines and early jawline softening sit in the plane this device treats. - **People who want minimal downtime and an indication-specific plan.** Most patients in the reported series returned to usual activity the same day; session count varies by indication and protocol. - **Atrophic acne scarring, in the right hands.** A 2025 series in Asian patients reported significant reduction in scar depression volume after a single session, with follow-up to eight months. It is a small, retrospective study, and scarring is treated as its own consultation rather than an add-on. See the [acne-scar study comparison](https://sofwave-seoul.com/sofwave-acne-scars/) for the separate multicenter evidence and its limits. - **Patients who understand the timeline.** The change appears over months. Someone comfortable with that is a far better candidate than someone who is not, regardless of how their skin looks. ### Poor candidates - **Advanced laxity with significant tissue descent.** A device confined to the mid-dermis will under-deliver where the problem is deeper. The appropriate answer is a different modality or a surgical opinion, and being told so is better service than being sold a session. - **Anyone expecting fat reduction or contouring.** Sofwave targets the dermis and is not a fat-reduction device. - **Anyone expecting deep static folds to disappear.** The measurable change in the published studies is in firmness, texture and modest fold depression volume, not in erasing established folds. - **Anyone on a deadline.** If the wedding is in three weeks, this is the wrong treatment for that timeline. - **Anyone who has been promised a "permanent" result.** No published evidence supports permanence for any non-surgical tightening device, and a clinic that says otherwise has told you something useful about itself. ### What the examination screens for These are the categories a dermatologist checks before treating with a heat-delivering device. They are not all absolute bars; several are timing or planning questions. - **Pregnancy and breastfeeding.** Elective aesthetic energy treatments are deferred; there is no safety evidence to justify treating. - **Active infection or open lesions in the treatment area.** Active herpes simplex, cellulitis, inflamed cystic acne or broken skin means the area is not treated until it settles. - **Recent fillers, threads or other injectables in the area.** Heat interacts with implanted material, and threads change the tissue plane. The interval is set by what was placed, how much and when. That is why the treatment history matters more than most patients expect. - **Keloid or hypertrophic scarring history.** Any controlled thermal injury is assessed more cautiously in someone who scars abnormally. - **Implanted electronic or metallic devices.** Declared and assessed against the manufacturer's instructions for use for the specific device and its location; this is checked rather than assumed either way. - **Uncontrolled systemic illness, autoimmune or connective tissue disease.** Wound healing is the mechanism this treatment relies on. If healing is impaired, the premise is weaker. - **Photosensitizing medication and recent isotretinoin.** Declared so timing can be planned. - **Expectations that do not match the mechanism.** Expectations beyond the capabilities of the treatment can lead to disappointment. ### Skin type and pigmentation The published series include Fitzpatrick types II–IV and Asian patient populations, and no post-inflammatory hyperpigmentation was reported in them. That is reassuring but comes from small samples, so pigmentation risk is still discussed individually, particularly for patients with a history of melasma or post-inflammatory pigmentation, where any heat-based treatment warrants a more careful conversation. ### What happens if you are not a candidate The examination sometimes concludes that this device is not the right answer. That conclusion is worth more than a treatment that was never going to work, and it is the reason candidacy cannot be settled by messenger before you arrive. A treatment protocol and other available options are described on [Delight Dermatology Clinic’s Sofwave treatment page](https://hifuseoul.com/procedures/sofwave-seoul/). Where the alternative is a different energy device, the [comparison page](https://sofwave-seoul.com/sofwave-vs-ultherapy/) explains how that choice is reasoned through. ### Published references 1. Gold MH, Biron J. Efficacy and safety of high-intensity, high-frequency, non-focused ultrasound parallel beams for facial skin laxity. *Journal of Cosmetic Dermatology*. 2024;23(1):117–123. [PubMed](https://pubmed.ncbi.nlm.nih.gov/38031530/) · doi:10.1111/jocd.16098 2. Hongcharu W, Boonchoo K, Gold MH. The efficacy and safety of the high-intensity parallel beam ultrasound device at the depth of 1.5 mm for skin tightening. *Journal of Cosmetic Dermatology*. 2023;22(5):1488–1494. [PubMed](https://pubmed.ncbi.nlm.nih.gov/36757157/) · doi:10.1111/jocd.15672 3. Boonchoo K, Hongcharu W. The efficacy and safety of a single treatment of high-intensity, high-frequency, non-focused ultrasound parallel beams for facial acne scars in Asian patients: a preliminary study. *Journal of Cosmetic Dermatology*. 2025;24(4):e70134. [PubMed](https://pubmed.ncbi.nlm.nih.gov/40132902/) · doi:10.1111/jocd.70134 4. Liao D, Prasad A, Bloom JD. Use of ultrasound in face and neck rejuvenation. *Facial Plastic Surgery*. 2026 (online ahead of print). [PubMed](https://pubmed.ncbi.nlm.nih.gov/41985490/) · doi:10.1055/a-2854-6601 ## Sofwave: frequently asked questions Source: https://sofwave-seoul.com/faq/ Updated: 2026-10-20 Sofwave uses non-focused ultrasound to treat the dermis. Treatment areas, session count and follow-up are agreed at consultation. ### How should I compare Sofwave clinics in Seoul? Confirm who will assess and treat you, their specialist credentials, the exact device, the treatment areas, and what the written quote includes. If you are visiting from abroad, ask about language support for your appointment and follow-up after returning home. ### How long does a Sofwave session take? Published reports describe sessions of roughly 30 to 60 minutes depending on how many areas are treated. That is the treatment itself; allow additional time for check-in, consultation and topical anesthetic. ### Does Sofwave hurt? Each pulse produces a brief sensation of heat. Mean pain scores in the published series range from about 3.9 to 6.6 on a 0-10 scale depending on the protocol and area, which is a wide range and uncomfortable at the upper end. Topical anesthetic is standard. Pain tolerance is worth raising at the consultation. ### When will I see a result? Early tightness may reflect transient tissue responses, including thermal contraction and swelling. Assess sustained improvement over subsequent months. The measurable change develops over weeks to months as new collagen forms; studies found significant change at one and three months, with the two-to-three-month visit the meaningful assessment point. ### How long do the results last? Some clinical studies followed outcomes for six months; an acne-scar case series followed patients for up to eight months. A separate biopsy study documented tissue remodeling for up to ten months. ### How deep does Sofwave treat? At a target treatment depth of about 1.5 mm, in the mid-dermis, with thermal zones spanning roughly 0.5 to 2 mm. Sofwave targets the dermis and is not a fat-reduction device; reported biopsy studies found thermal injury confined to the dermis. ### How is Sofwave different from Ultherapy? Seven synchronized, non-focused ultrasound beams create separate cylindrical thermal zones in the dermis, centered approximately 1.5 mm deep. Ultherapy uses microfocused ultrasound with visualization to place discrete points at selectable depths of 1.5, 3.0 and 4.5 mm, the deepest of which can reach the SMAS, and it images the tissue before delivery. They share the 1.5 mm plane. A small randomized split-body trial compared Sofwave and Ultherapy for upper-inner-arm laxity. Its findings should not be generalized to facial or neck treatment. ### Is Sofwave "FDA approved"? It is FDA cleared, which is a different regulatory pathway from approval. The cleared indications are improvement of facial lines and wrinkles (2019), lifting the eyebrow and lifting lax submental and neck tissue in subjects aged 22 and older (2021), short-term improvement in the appearance of cellulite (2022), treatment of acne scars (2023), and improvement of the appearance of upper-arm skin laxity (2023). Any use outside the cleared indications is off-label. ### How much does Sofwave cost in Seoul? [Delight Dermatology Clinic](https://hifuseoul.com/procedures/sofwave-seoul/) lists around KRW 2,000,000–2,200,000 per Sofwave session. The final amount is confirmed at consultation based on the treatment area and agreed plan. Using the Federal Reserve’s 28 August 2026 rate of KRW 1,379.41 per US dollar, this is approximately USD 1,450–1,595. ### How many sessions will I need? The number of sessions depends on the treatment area and plan. The upper-arm study in K233104 used two sessions, 1–3 weeks apart. Ask your clinician to explain the proposed schedule and when your response will be assessed. ### Can I fly home the next day? Most people resume usual activity the same day and there is no dressing or scheduled recovery. Mild redness or tenderness on pressure may persist for a day or two. Travel plans are worth mentioning at consultation so the plan can account for them. ### Can Sofwave be combined with fillers or botulinum toxin? Often, but the sequence and interval matter because heat interacts with implanted material and threads change the tissue plane. Declare everything that has been placed in the treatment area and when, and let the clinician set the order. This is planned at examination, not improvised. ### Will Sofwave replace a facelift? No. It suits mild to moderate laxity in the dermal plane. Where laxity is advanced or the deeper support structures have descended, a device confined to the mid-dermis will under-deliver, and a surgical opinion is the more honest answer. Source: [FDA K233104 510(k) summary](https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233104.pdf). Read the [upper-arm sessions and evidence guide](https://sofwave-seoul.com/sofwave-upper-arms/). Price and conversion sources: [Delight’s published Sofwave price](https://hifuseoul.com/procedures/sofwave-seoul/) · [Federal Reserve H.10 (2026-08-28)](https://www.federalreserve.gov/releases/h10/20260831/) See [how to choose a Sofwave clinic in Seoul](https://sofwave-seoul.com/#choosing-a-clinic). ### Published references 1. Boonchoo K, Hongcharu W. The efficacy and safety of a single treatment of high-intensity, high-frequency, non-focused ultrasound parallel beams for facial acne scars in Asian patients: a preliminary study. *Journal of Cosmetic Dermatology*. 2025;24(4):e70134. [PubMed](https://pubmed.ncbi.nlm.nih.gov/40132902/) · doi:10.1111/jocd.70134 2. Carruthers J, Benitez Roig V, McDaniel DH, Jackson B, Bedich O, Amir R, Eckhouse S. Synchronous parallel ultrasound induces long-term extracellular matrix remodeling of human skin. *Dermatologic Surgery*. 2025;51(9S):S58–S64. [PubMed](https://pubmed.ncbi.nlm.nih.gov/41405933/) · doi:10.1097/DSS.0000000000004793 · Author group includes employees of the device manufacturer. 3. Loyal J, Hartman N, Goldman MP. A Single-Center, Blinded, Split-Body, Randomized Clinical Trial of High-Intensity, Parallel Ultrasound Beams Versus Microfocused Ultrasound With Visualization for the Treatment of Upper Inner Arm Skin Laxity. *Dermatologic Surgery*. 2026;52(4):349–354. [PubMed](https://pubmed.ncbi.nlm.nih.gov/41025649/) · doi:10.1097/DSS.0000000000004881 4. Hongcharu W, Boonchoo K, Gold MH. The efficacy and safety of the high-intensity parallel beam ultrasound device at the depth of 1.5 mm for skin tightening. *Journal of Cosmetic Dermatology*. 2023;22(5):1488–1494. [PubMed](https://pubmed.ncbi.nlm.nih.gov/36757157/) · doi:10.1111/jocd.15672 5. Gold MH, Biron J. Efficacy and safety of high-intensity, high-frequency, non-focused ultrasound parallel beams for facial skin laxity. *Journal of Cosmetic Dermatology*. 2024;23(1):117–123. [PubMed](https://pubmed.ncbi.nlm.nih.gov/38031530/) · doi:10.1111/jocd.16098 6. Suh DH, Lee SJ, Song KY, Ahn HJ, Shin MK. High-intensity, parallel ultrasound tightening of facial skin: clinical and pathologic results. *Journal of Cosmetic Dermatology*. 2025;24(2):e16670. [PubMed](https://pubmed.ncbi.nlm.nih.gov/39530193/) · doi:10.1111/jocd.16670 7. Liao D, Prasad A, Bloom JD. Use of ultrasound in face and neck rejuvenation. *Facial Plastic Surgery*. 2026 (online ahead of print). [PubMed](https://pubmed.ncbi.nlm.nih.gov/41985490/) · doi:10.1055/a-2854-6601 ## Is Sofwave a laser? Ultrasound and laser energy, explained Source: https://sofwave-seoul.com/is-sofwave-a-laser/ Updated: 2026-10-18 No. Sofwave is an ultrasound device, not a laser. FDA's 510(k) summaries describe the SofWave System as an ultrasound system whose transducers emit acoustic waves at 10–12 MHz and raise the temperature of the dermis while a cooling element cools the skin surface. [[1]](https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191421.pdf) A laser heats with light of one specific wavelength, absorbed by a target such as pigment or a blood vessel. [[2]](https://www.fda.gov/radiation-emitting-products/home-business-and-entertainment-products/laser-products-and-instruments) [[3]](https://pubmed.ncbi.nlm.nih.gov/6836297/) The two energies raise different questions about eye protection, skin type and what is being heated. Figure: Ripples spreading across calm water on one side, and a single straight beam of pale light passing through a clear glass block on the other. Sound and light: two different forms of energy. ### What the FDA record says Sofwave is Sofwave's first US clearance, K191421, was decided on September 9, 2019, when the device was called the Sofacia System. Its 510(k) summary describes “an ultrasound system intended for aesthetic purposes” that generates high-frequency ultrasonic pulses to raise the temperature in the dermis. The comparison table lists the energy type as high-intensity ultrasound, the frequency as 10–12 MHz and the treatment depth as 1–2 mm. The applicator pairs an array of ultrasonic transducers with a thermoelectric cooler that keeps the epidermis cool. [[1]](https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191421.pdf) The device is filed under 21 CFR 878.4590, product code OHV, the same regulation as the Ulthera System it was compared with in 2019. The category is named for focused ultrasound; the later K233104 summary describes Sofwave's technology as “high intensity non-focused ultrasound.” A 510(k) clearance covers the listed US indications; it is not an approval and does not cover authorization in Korea. [[1]](https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191421.pdf) [[4]](https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233104.pdf) ### How a laser heats skin Figure: One thin beam of light passing through a clear glass prism on a dark table without splitting into colors. A single beam, standing in for laser light of one wavelength. FDA explains that laser stands for light amplification by the stimulated emission of radiation, and that laser light has a specific wavelength where ordinary light mixes many. Laser manufacturers must comply with FDA's performance standards for laser products, 21 CFR 1040.10 and 1040.11. Lasers used in medicine must also comply with the medical device regulations. [[2]](https://www.fda.gov/radiation-emitting-products/home-business-and-entertainment-products/laser-products-and-instruments) In skin, a laser's heat forms where its light is absorbed. The 1983 paper that described selective photothermolysis showed that brief pulses of selectively absorbed light could damage pigmented structures or small blood vessels, depending on the wavelength used. [[3]](https://pubmed.ncbi.nlm.nih.gov/6836297/) ### How Sofwave heats skin instead Figure: Concentric ripples spreading across a still, shallow pool of water in evening light. Ripples, standing in for the sound waves of ultrasound. Ultrasound is sound, a pressure wave pitched far above human hearing. In the SofWave System, seven transducers sit in direct contact with the skin and send parallel beams with a target treatment depth of about 1.5 mm in the dermis. [[5]](https://pubmed.ncbi.nlm.nih.gov/41985490/) [[6]](https://pubmed.ncbi.nlm.nih.gov/39530193/) Part of that acoustic energy turns into heat in the tissue. [[1]](https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191421.pdf) One published Korean protocol applied a topical anesthetic cream and then an ultrasound gel before treatment. [[6]](https://pubmed.ncbi.nlm.nih.gov/39530193/) Two biopsy studies place the effect in the dermis. A report on 13 women treated once in Korea found collagen remodeling at 1–3 mm from the epidermis two months later. [[6]](https://pubmed.ncbi.nlm.nih.gov/39530193/) A study that used a pig model for the acute heat injury, and human biopsies for ten months afterwards, reported that the thermal injury was restricted to the dermal layer. Its author group includes authors affiliated with Sofwave Medical. [[7]](https://pubmed.ncbi.nlm.nih.gov/41405933/) ### How it differs from other ultrasound devices Ultrasound devices for skin do not all deliver energy the same way. Microfocused ultrasound converges energy to small points. A 2026 review describes microfocused ultrasound with visualization treating at depths from 1.5 to 4.5 mm, down to the superficial musculoaponeurotic system (SMAS), while SUPERB delivers energy at a fixed 1.5 mm. [[5]](https://pubmed.ncbi.nlm.nih.gov/41985490/) The 2019 FDA comparison shows the same split in hardware: the predicate used a focused, dome-shaped transducer at 4–10 MHz, and Sofwave an array of piezoelectric plates at 10–12 MHz. [[1]](https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191421.pdf) For treatment depths side by side, see [Sofwave vs Ultherapy](https://sofwave-seoul.com/sofwave-vs-ultherapy/); for device parameters, see [what Sofwave is and how it works](https://sofwave-seoul.com/what-is-sofwave/). Figure: Schematic of two energy types: a laser uses light of one specific wavelength that a target such as pigment or a blood vessel absorbs; Sofwave uses 10–12 MHz ultrasound from seven parallel transducers to heat a dermal layer about 1.5 mm deep while the surface is cooled. Two energy types side by side. Sources: [FDA K191421](https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191421.pdf) and [K233104](https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233104.pdf); [FDA Laser Products and Instruments](https://www.fda.gov/radiation-emitting-products/home-business-and-entertainment-products/laser-products-and-instruments); [Anderson and Parrish](https://pubmed.ncbi.nlm.nih.gov/6836297/); [Liao et al.](https://pubmed.ncbi.nlm.nih.gov/41985490/); [Suh et al.](https://pubmed.ncbi.nlm.nih.gov/39530193/) ### Three questions the energy type changes #### Eye protection FDA lists medical lasers for eye surgery or skin treatment among its Class IV examples, a class with an immediate eye and skin hazard from the direct or reflected beam. [[2]](https://www.fda.gov/radiation-emitting-products/home-business-and-entertainment-products/laser-products-and-instruments) For a laser treatment, ask what eye protection you and the staff will wear. The Sofwave 510(k) summaries describe ultrasound energy but do not set out eye-protection requirements. [[1]](https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191421.pdf) [[4]](https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233104.pdf) Ask the clinician which precautions the device instructions require for the planned area. #### Skin type With many lasers, skin color is a central safety question. A review of laser and light treatment for Fitzpatrick skin types V and VI describes a greater risk of pigment change and scarring in skin with more epidermal melanin, and calls for careful choice of device and settings. [[8]](https://pubmed.ncbi.nlm.nih.gov/24098905/) Because the FDA summaries describe acoustic rather than optical energy, Sofwave's heating does not rely on light absorption by melanin. [[1]](https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191421.pdf) That does not establish its risk of pigment change or scarring in darker skin, or its safety compared with lasers. The studies enrolled Fitzpatrick types I–VI in the multicenter acne-scar study, I–IV in the upper-arm study, and, in the Korean biopsy report, twelve people of type III or IV and one of type V. [[9]](https://pubmed.ncbi.nlm.nih.gov/40152353/) [[10]](https://pubmed.ncbi.nlm.nih.gov/40152327/) [[6]](https://pubmed.ncbi.nlm.nih.gov/39530193/) The two multicenter abstracts do not report outcomes by skin type. - Which studies included people with my skin type, and how many? - Which pigment or scarring risks apply to my skin, and how would they be managed? #### What is being heated For either treatment, ask which tissue is being targeted. Sofwave has a target ultrasound treatment depth of about 1.5 mm. [[5]](https://pubmed.ncbi.nlm.nih.gov/41985490/) Ask how the skin surface is protected and why that depth matches your concern. If the concern is pigment, visible vessels or deeper tissue, ask which other treatments should be compared. [Delight Dermatology Clinic’s Sofwave treatment page](https://hifuseoul.com/procedures/sofwave-seoul/) describes its treatment protocol. For screening factors, see [candidates and contraindications](https://sofwave-seoul.com/candidates-and-contraindications/). ### Common questions ### Is Sofwave a laser? No. FDA 510(k) summaries describe the SofWave System as an ultrasound system whose transducers emit acoustic waves at 10–12 MHz to raise the temperature of the dermis. A laser uses light of a specific wavelength. ### Does Sofwave need laser eye protection? Sofwave is not a laser, but that does not settle which eye precautions apply. The SofWave 510(k) summaries describe ultrasound energy but do not set out eye-protection requirements. Ask the clinician which precautions the device instructions require for the planned area. ### Is Sofwave safe for darker skin because it is not a laser? Not on that reasoning. Because the FDA summaries describe acoustic rather than optical energy, its heating does not rely on light absorption by melanin, but that does not establish its risk of pigment change or scarring in darker skin. Ask which studies included people with your skin type, and how many. ### Is Sofwave the same as focused ultrasound? Both heat tissue with ultrasound, but the geometry differs. Microfocused ultrasound converges energy to points at selectable depths, while Sofwave sends parallel, non-focused beams to one fixed depth of about 1.5 mm. ### Why does the FDA category mention focused ultrasound? The SofWave System is filed under 21 CFR 878.4590, a category named for focused ultrasound that it shares with focused devices. Its K233104 summary describes the technology itself as high intensity non-focused ultrasound. ### Sources 1. [US FDA. K191421 510(k) summary, Sofacia System (now the SofWave System). Decision date September 9, 2019. Device description and comparison table.](https://www.accessdata.fda.gov/cdrh_docs/pdf19/K191421.pdf) 2. [US FDA. Laser Products and Instruments. Content current as of November 13, 2024.](https://www.fda.gov/radiation-emitting-products/home-business-and-entertainment-products/laser-products-and-instruments) 3. [Anderson RR, Parrish JA. Selective photothermolysis: precise microsurgery by selective absorption of pulsed radiation. Science, 1983. PMID 6836297.](https://pubmed.ncbi.nlm.nih.gov/6836297/) 4. [US FDA. K233104 510(k) summary, SofWave System. Decision date December 22, 2023. Classification name and technology row of the comparison table.](https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233104.pdf) 5. [Liao D, Prasad A, Bloom JD. Use of ultrasound in face and neck rejuvenation. Facial Plastic Surgery, 2026. PMID 41985490. Review.](https://pubmed.ncbi.nlm.nih.gov/41985490/) 6. [Suh DH, Lee SJ, Song KY, Ahn HJ, Shin MK. High-intensity, parallel ultrasound tightening of facial skin: clinical and pathologic results. Journal of Cosmetic Dermatology, 2025. PMID 39530193. The authors declared no conflicts of interest.](https://pubmed.ncbi.nlm.nih.gov/39530193/) 7. [Carruthers J, et al. Synchronous parallel ultrasound induces long-term extracellular matrix remodeling of human skin. Dermatologic Surgery, 2025. PMID 41405933. Includes authors affiliated with Sofwave Medical.](https://pubmed.ncbi.nlm.nih.gov/41405933/) 8. [Alexis AF. Lasers and light-based therapies in ethnic skin: treatment options and recommendations for Fitzpatrick skin types V and VI. British Journal of Dermatology, 2013. PMID 24098905. Review.](https://pubmed.ncbi.nlm.nih.gov/24098905/) 9. [Wang JV, et al. High-intensity, high-frequency, parallel ultrasound beams for facial acne scars. Dermatologic Surgery, 2025. PMID 40152353.](https://pubmed.ncbi.nlm.nih.gov/40152353/) 10. [Wang JV, et al. High-intensity, high-frequency, parallel ultrasound beam device for skin laxity of the upper arms. Dermatologic Surgery, 2025. PMID 40152327.](https://pubmed.ncbi.nlm.nih.gov/40152327/) ## Sofwave Cost in Seoul: Price Scope and What Affects It Source: https://sofwave-seoul.com/pricing-seoul/ Updated: 2026-10-18 [Delight Dermatology Clinic](https://hifuseoul.com/procedures/sofwave-seoul/) lists around KRW 2,000,000–2,200,000 per Sofwave session. The final amount is confirmed at consultation based on the treatment area and agreed plan. Using the Federal Reserve’s 28 August 2026 rate of KRW 1,379.41 per US dollar, this is approximately USD 1,450–1,595. The number and timing of sessions depend on the indication and agreed treatment plan. Price and conversion sources: [Delight’s published Sofwave price](https://hifuseoul.com/procedures/sofwave-seoul/) · [Federal Reserve H.10 (2026-08-28)](https://www.federalreserve.gov/releases/h10/20260831/) Figure: Two rectangular fields of dots side by side, the left sparse and the right densely filled The illustration compares sparse and dense dot patterns. Ask how the planned pulses and passes cover your treatment areas. ### What the example price covers The example is one clinic’s published range for a single session, checked on 18 October 2026. It is not a Seoul-wide or Korea-wide price range. Confirm the treatment areas and included services for your own quote. ### Why a quote can vary - **Treatment area and plan.** Ask whether the quote covers the full face, face with submental and neck areas, or a targeted area, and which plan has been agreed. - **Pulse and pass plan.** A study by [Suh and colleagues](https://doi.org/10.1111/jocd.16670) reported 150–200 pulses for both cheeks with 2–3 passes over the treated areas. These are study settings, not the clinic’s billing unit or a promised result. Ask how the proposed pulses and passes cover your treatment areas. - **What the examination finds.** Skin thickness, laxity distribution and prior treatments change the plan, and the plan sets the price. ### Confirm what the fee includes Confirm in writing whether consultation and examination, topical anesthetic when used, and post-treatment guidance are included in the Sofwave quote or billed separately. The published price is per session. The number and timing of sessions depend on the indication and agreed treatment plan. ### How to read Seoul pricing without being misled Seoul is a competitive aesthetic market, and price advertising here can be aggressive. A few things are worth checking on any clinic’s quote: - **Ask which device and areas the quote covers.** Confirm the device name, treatment areas and planned pulses and passes. Compare quotes with the same scope; pulse count alone does not tell you the price or expected result. - **Ask whether the quote is per session or per package.** Packages can be reasonable, but they commit you before anyone knows how your skin responds. - **Check what a low advertised price includes.** Ask which areas and services it covers and which charges are separate before comparing it with another quote. - **Treat a guaranteed outcome as a warning.** Nobody can guarantee an individual response to a collagen-remodeling treatment, and a clinic offering that guarantee is telling you something about its claims generally. ### Currency and payment for international patients Prices are set in Korean won. The USD estimate uses the historical rate stated above; it does not update with today’s rate. Confirm the payable KRW amount at consultation and the conversion rate applied by your payment provider. ### Where this sits against other treatments Treatment depths and mechanisms may differ or overlap. Compare the indication, treatment areas and agreed plan alongside prices. See the [Sofwave and Ultherapy comparison](https://sofwave-seoul.com/sofwave-vs-ultherapy/). ### Confirming the current figure [Sofwave pricing and consultation details in Seoul](https://hifuseoul.com/procedures/sofwave-seoul/) lists the clinic’s price range, treatment details and contact options. ## Sofwave for acne scars: two studies, different protocols Source: https://sofwave-seoul.com/sofwave-acne-scars/ Updated: 2026-10-18 Sofwave has been studied for facial acne scars, but the published reports do not describe one standard course. A prospective multicenter study allowed up to three treatments; a separate small retrospective series examined one. [[1]](https://pubmed.ncbi.nlm.nih.gov/40152353/) [[2]](https://pubmed.ncbi.nlm.nih.gov/40132902/) Figure: Study-design summary: 63 participants completed at least two treatments in the multicenter study; a separate retrospective series included 14 people after one treatment. Treatment schedules in two separate acne-scar studies. Sources: [Wang et al.](https://pubmed.ncbi.nlm.nih.gov/40152353/) and [Boonchoo and Hongcharu](https://pubmed.ncbi.nlm.nih.gov/40132902/). ### What the US FDA record covers The FDA database dates the SofWave System decision K231537 to August 28, 2023. The later K233104 indications document includes treatment of acne scars. [[3]](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231537) [[4]](https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233104.pdf) ### The multicenter study: scar-severity scores In the 2025 prospective report, 63 participants completed at least two treatments under a protocol allowing up to three. Skin types I–VI were represented. The investigators compared baseline with the three-month assessment. [[1]](https://pubmed.ncbi.nlm.nih.gov/40152353/) The average acne-scar severity score fell from 2.31 to 1.26. The study also reported a blinded photograph-identification endpoint; that is a different measure from severity. [[1]](https://pubmed.ncbi.nlm.nih.gov/40152353/) ### The single-session report answers a different question The separate Thai series retrospectively assessed 14 people after one treatment, with follow-up extending up to eight months. It used photographs, clinical ratings and three-dimensional depression measurements. [[2]](https://pubmed.ncbi.nlm.nih.gov/40132902/) Study design at a glance | Study | Participants | Sessions | Assessment | | --- | --- | --- | --- | | Prospective, multicenter [1] | 63 completers | At least 2; up to 3 planned | 3 months | | Retrospective, Thailand [2] | 14 | 1 | Up to 8 months | ### Safety findings and unanswered comparisons The multicenter paper reported no device-related adverse events; the smaller series reported no adverse events and a mean pain score of 3.94 on an 11-point scale. [[1]](https://pubmed.ncbi.nlm.nih.gov/40152353/) [[2]](https://pubmed.ncbi.nlm.nih.gov/40132902/) Neither report supplies a randomized head-to-head comparison with other acne-scar procedures. Their designs, session counts and outcome measures differ. [[1]](https://pubmed.ncbi.nlm.nih.gov/40152353/) [[2]](https://pubmed.ncbi.nlm.nih.gov/40132902/) ### Questions for an acne-scar consultation - Which scar pattern and treatment goal does the proposed plan address? - Which study supports the proposed number of sessions and assessment date? - What alternatives should be compared for this pattern, and why? - How will change be documented, and what follow-up is available if symptoms persist? See [candidate assessment and cautions](https://sofwave-seoul.com/candidates-and-contraindications/) for the broader Sofwave context. See also [upper-arm laxity](https://sofwave-seoul.com/sofwave-upper-arms/) and [facial lifting comparisons](https://sofwave-seoul.com/sofwave-vs-ultherapy/). ### Common questions ### Is Sofwave FDA cleared for acne scars? The US FDA record K231537 documents the SofWave System decision in August 2023. The subsequent K233104 labeling includes treatment of acne scars. ### How many Sofwave sessions were studied for acne scars? The prospective multicenter study allowed up to three treatments, with 63 participants completing at least two. A separate retrospective series studied one session in 14 people. ### How did the average scar-severity score change? The prospective study’s average scar-severity rating fell from 2.31 to 1.26 at the three-month assessment. ### Do these studies prove Sofwave is better than other acne-scar treatments? No. These reports do not provide a randomized head-to-head comparison with other acne-scar treatments. They differ in design, session count, follow-up and outcome measures. ### Sources 1. [Wang et al. Dermatologic Surgery, 2025. PMID 40152353.](https://pubmed.ncbi.nlm.nih.gov/40152353/) 2. [Boonchoo and Hongcharu. Journal of Cosmetic Dermatology, 2025. PMID 40132902.](https://pubmed.ncbi.nlm.nih.gov/40132902/) The authors declared no conflicts of interest. 3. [FDA K231537 decision record.](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K231537) 4. [FDA K233104: indications for use, page 4.](https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233104.pdf) ## Sofwave before and after: how trials judged brow and wrinkle photos Source: https://sofwave-seoul.com/sofwave-before-and-after/ Updated: 2026-10-24 In the study summarized in FDA 510(k) record K211483, masked reviewers identified the before and after brow photos correctly for 79% (53 of 67) of treated subjects, and quantitative 2D imaging measured an average lift of 0.78 mm for maximal eyebrow height. [[1]](https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211483.pdf) In a 2026 study of 42 Asian adults treated once, eyebrow elevation was rated improved in 28.6% at 3 months and 20.5% at 9 months, and facial wrinkles in 38.1% and 15.4%. [[2]](https://pubmed.ncbi.nlm.nih.gov/42226470/) Figure: Two panels. Left, K211483 Zone 1: brow photos in the right order for 79% of treated subjects (53 of 67), average lift 0.78 mm MEH and 0.69 mm AEH, 80% improved on PGAIS (51 of 64) at the 3-month visit. Right, bar chart from Chung 2026: eyebrow elevation improved in 28.6%, 26.2% and 20.5%, facial wrinkles in 38.1%, 23.8% and 15.4% at 3, 6 and 9 months. Two studies, two measures. Sources: [FDA K211483](https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211483.pdf); [Chung et al.](https://pubmed.ncbi.nlm.nih.gov/42226470/), Table 3. ### Gallery photos and trial photos Sofwave's manufacturer keeps a before-and-after gallery sorted by treatment area, with tabs for the neck, eyebrows, submental area and wrinkles among others. Each card shows one person, names the clinician or clinic that supplied the photos and carries a time label such as “12 Weeks” or “3 Months”. None of the neck, eyebrow, submental or wrinkle cards states how many sessions were given. [[3]](https://sofwave.com/patients/before-after) The eyebrow and wrinkle tabs cover areas that trials scored from photographs: K211483 measured the brow, and a 2026 study rated eyebrow elevation and facial wrinkles. [[1]](https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211483.pdf) [[2]](https://pubmed.ncbi.nlm.nih.gov/42226470/) ### How the K211483 study judged brow photos K211483 is the US FDA 510(k) record for the SofWave System dated November 15, 2021. Its 510(k) summary describes a clinical study at five investigational sites in the United States: 92 subjects were enrolled and 80 treated. Each was treated on three zones: the forehead and temples for eyebrow lifting (Zone 1), the cheeks (Zone 2), and the submental area and neck (Zone 3). [[1]](https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211483.pdf) Sofwave's applicator sends seven parallel ultrasound beams to the mid-dermis, at a depth of about 1.5 mm, while a cooling element cools the skin it touches. [[2]](https://pubmed.ncbi.nlm.nih.gov/42226470/) [[4]](https://pubmed.ncbi.nlm.nih.gov/41985490/) [[1]](https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211483.pdf) Zone 1 had two co-primary endpoints. In the first, independent masked evaluators were shown each subject's image sequence and had to identify which photo was taken before treatment and which after. With two reviewers in agreement, they did so for 79% (53/67) of treated subjects. In the second, quantitative 2D imaging measured an average lift of 0.78 mm for maximal eyebrow height (MEH) and 0.69 mm for average eyebrow height (AEH). [[1]](https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211483.pdf) Figure: Two bars on a magnified scale from 0 to 1 mm: maximal eyebrow height 0.78 mm and average eyebrow height 0.69 mm. Average brow lift in Zone 1. Source: [FDA K211483](https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211483.pdf), summary page 5. The two numbers answer different questions. The order test asks whether an evaluator who did not know the order could see a change; the 2D measurement gives its size, under one millimetre at the brow. As a secondary endpoint, 80% (51/64) of subjects were rated improved on the Physician Global Aesthetic Improvement Scale (PGAIS) at the 3-month follow-up visit. [[1]](https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211483.pdf) ### Brow and wrinkle results over nine months A 2026 study by dermatologists at the University of Hong Kong followed 42 Asian adults aged 35 to 67, 40 of them women, after a single treatment of the full face, the neck and the submental area. It was prospective and open-label, with no control group. All 42 returned at 3 and 6 months and 39 at 9 months. Sofwave Medical Ltd. funded the study. [[2]](https://pubmed.ncbi.nlm.nih.gov/42226470/) Photographs were taken with a configurable head support, under four lighting conditions, from the front and from each side at 37°. Two assessors, blinded to the time point and to each other's rating, scored each case on the PGAIS, which runs from −1 (worsened) to 3 (very much improved); the two ratings were averaged. [[2]](https://pubmed.ncbi.nlm.nih.gov/42226470/) Participants rated improved on the PGAIS after one treatment, Chung et al. 2026, Table 3 | Rated improved | 3 months (n = 42) | 6 months (n = 42) | 9 months (n = 39) | | --- | --- | --- | --- | | Eyebrow elevation | 12 (28.6%) | 11 (26.2%) | 8 (20.5%) | | Facial wrinkles | 16 (38.1%) | 10 (23.8%) | 6 (15.4%) | Both shares were lower at 9 months than at 3. The authors report that efficacy across the treated areas gradually declined over the nine months and suggest that periodic maintenance treatments may be needed to sustain the initial effect. [[2]](https://pubmed.ncbi.nlm.nih.gov/42226470/) The same study rated submental and neck laxity on the same scale; those results, with the K211483 neck zone, are in [Sofwave under the chin and on the neck](https://sofwave-seoul.com/sofwave-neck-and-under-chin/). ### Who looked at the photos In K211483, independent masked evaluators made the before-or-after call. In the 2026 study, two assessors did not know the time point of the photos they scored. In a smaller 2024 study of 15 people aged 40 to 69 who had two sessions, the study investigators graded the baseline and follow-up photographs with the PGAIS themselves, at 3 and 6 months. [[1]](https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211483.pdf) [[2]](https://pubmed.ncbi.nlm.nih.gov/42226470/) [[5]](https://pubmed.ncbi.nlm.nih.gov/38031530/) Figure: Three panels: an order test with two unlabeled photo frames, 79% of treated subjects in the right order; a 2D measurement of a line raised above a dashed baseline, 0.78 mm; a graded score on a scale from −1 to 3, eyebrow elevation rated improved in 28.6% at 3 months. Three ways to judge a before-and-after. Sources: [FDA K211483](https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211483.pdf); [Chung et al.](https://pubmed.ncbi.nlm.nih.gov/42226470/) ### What treated people reported The K211483 summary also reports a patient questionnaire. For the eyebrow lift, 55% of subjects reported improvement and satisfaction. Asked whether they would undergo further treatments, 37 of 64 (58%) said yes; the rest said no or were not sure. The mean pain level during treatment was 6.4 out of 10 for Zone 1. One device-related adverse event was reported in the study; it was moderate and transient and resolved with topical cream alone. [[1]](https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211483.pdf) ### Is Sofwave worth it for brows and wrinkles? Weigh the brow and wrinkle results against [what a session costs in Seoul](https://sofwave-seoul.com/pricing-seoul/) and the change you hope for; for screening factors, see [candidates and contraindications](https://sofwave-seoul.com/candidates-and-contraindications/). [Delight Dermatology Clinic’s Sofwave treatment page](https://hifuseoul.com/procedures/sofwave-seoul/) describes its treatment protocol. ### Common questions ### Are Sofwave before-and-after photos measured? A gallery photo shows one person. In the study summarized in FDA record K211483, masked reviewers put the brow photos in the right before-and-after order for 79% (53/67) of treated subjects, and quantitative 2D imaging measured an average lift of 0.78 mm for maximal eyebrow height. ### When are Sofwave brow and wrinkle results judged? In a 2026 study of 42 Asian adults treated once, eyebrow elevation was rated improved in 28.6%, 26.2% and 20.5% at 3 months, 6 months and 9 months, and facial wrinkles in 38.1%, 23.8% and 15.4%. In the K211483 study, 80% (51/64) were rated improved on the PGAIS at the 3-month visit. ### What do people treated with Sofwave report? In the K211483 patient questionnaire, 55% of subjects reported improvement and satisfaction for the eyebrow lift. ### Is Sofwave worth it? In the K211483 patient questionnaire, 37 of 64 subjects (58%) said they would undergo further treatments. Set the brow and wrinkle results against the cost of a session and the change you want. ### How many Sofwave sessions are behind a before-and-after photo? The manufacturer’s gallery cards for the brow and wrinkles, and for the neck and submental area, do not state a session count. The 2026 study used one treatment, and a 2024 study of 15 people used two sessions. ### Sources 1. [US FDA. K211483, SofWave System: letter dated November 15, 2021 and 510(k) summary. Clinical study on summary pages 5–6.](https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211483.pdf) 2. [Chung MMH, Wong CSM, Chan MWM, Shek SYN, Yeung CK, Chan HHL. Evaluating the use of high-intensity non-focused ultrasound treatment to improve skin laxity and facial wrinkles in Asian patients. Lasers in Surgery and Medicine, 2026. PMID 42226470. Study funding: Sofwave Medical Ltd.](https://pubmed.ncbi.nlm.nih.gov/42226470/) 3. [Sofwave Medical. Before and After Gallery, with tabs for the neck, the eyebrows, the submental area and wrinkles. Accessed October 24, 2026.](https://sofwave.com/patients/before-after) 4. [Liao D, Prasad A, Bloom JD. Use of ultrasound in face and neck rejuvenation. Facial Plastic Surgery, 2026. PMID 41985490. Review.](https://pubmed.ncbi.nlm.nih.gov/41985490/) 5. [Gold MH, Biron J. Efficacy and safety of high-intensity, high-frequency, non-focused ultrasound parallel beams for facial skin laxity. Journal of Cosmetic Dermatology, 2024. PMID 38031530.](https://pubmed.ncbi.nlm.nih.gov/38031530/) ## Sofwave under the chin and on the neck: what 38 mm² means Source: https://sofwave-seoul.com/sofwave-neck-and-under-chin/ Updated: 2026-10-24 In the study summarized in FDA 510(k) record K211483, quantitative 2D imaging measured an average lift of 38 mm² of lax submental and neck tissue, an area rather than a height, and masked reviewers identified the before and after photos correctly for 80% (60 of 75) of treated subjects. [[1]](https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211483.pdf) In a 2026 study of 42 Asian adults treated once, assessors rated submental and neck laxity improved in 71.4% at 6 months and 69.2% at 9 months. [[2]](https://pubmed.ncbi.nlm.nih.gov/42226470/) Figure: Four numbers for K211483 Zone 3: photos in the right order for 80% of treated subjects (60 of 75), 38 mm² average lift on 2D images, 85% improved on PGAIS at the 3-month visit (61 of 72), mean pain 5.3 out of 10; beside them, a 35 mm bar and a 38 mm² square drawn to one scale. Zone 3 in four numbers. Source: [FDA K211483](https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211483.pdf), summary pages 4–6. ### What the K211483 study measured under the chin K211483 is the US FDA 510(k) record for the SofWave System dated November 15, 2021. The clinical study in its summary enrolled 92 subjects and treated 80 at five US sites, on three zones each; Zone 3 was the submental area (beneath the chin) and the neck. [[1]](https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211483.pdf) Zone 3 had two co-primary endpoints. Independent masked evaluators, shown each subject's image sequence, identified the before and after photos correctly for 80% (60/75) of treated subjects, based on the agreement of two reviewers. Quantitative 2D imaging measured an average lift of lax submental and neck tissue of 38 mm². As a secondary endpoint, 85% (61/72) were rated improved on the Physician Global Aesthetic Improvement Scale (PGAIS) at the 3-month follow-up visit. [[1]](https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211483.pdf) The same study measured the eyebrow as a distance in millimetres; see [how trials judged brow and wrinkle photos](https://sofwave-seoul.com/sofwave-before-and-after/). ### What 38 mm² means A square millimetre is a unit of area, so the neck result is a measured area of lift rather than a distance. The summary gives 38 mm² as an average from quantitative 2D imaging and does not describe the outline that was measured. For scale, 38 mm² is the area of a square about 6.2 mm on each side, and the record's comparison table gives the treatment area width as 35 mm. Because it comes from 2D images, it is not a volume. [[1]](https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211483.pdf) Sofwave delivers its energy at a fixed depth of 1.5 mm in the mid-dermis. [[3]](https://pubmed.ncbi.nlm.nih.gov/41985490/) ### After one treatment: 3, 6 and 9 months A 2026 study by dermatologists at the University of Hong Kong treated 42 Asian adults once over the full face, the neck and the submental area and followed them for nine months. It was open-label, with no control group, and Sofwave Medical Ltd. funded it. On the neck and submental area, pulses averaged 3.41 J with a mean of 3.5 passes, and the protocol called for 30%–50% overlap for each pulse. [[2]](https://pubmed.ncbi.nlm.nih.gov/42226470/) Two assessors, blinded to the time point, rated submental and neck laxity improved in 35 of 42 (83.3%) at 3 months, 30 of 42 (71.4%) at 6 months and 27 of 39 (69.2%) at 9 months. Satisfaction with the submental and neck result was 64.3%, 57.2% and 38.5% at the same visits. [[2]](https://pubmed.ncbi.nlm.nih.gov/42226470/) Figure: Bar chart from Chung 2026: submental and neck laxity rated improved in 83.3%, 71.4% and 69.2%, and satisfied with the result 64.3%, 57.2% and 38.5%, at 3, 6 and 9 months after one treatment. Submental and neck laxity after one treatment. Source: [Chung et al.](https://pubmed.ncbi.nlm.nih.gov/42226470/), Table 3 and section 3.4. At 9 months the share satisfied with the result, 38.5%, was lower than the share the assessors rated improved, 69.2%. [[2]](https://pubmed.ncbi.nlm.nih.gov/42226470/) The K211483 summary does not state a number of sessions. A 2024 study of 15 people aged 40 to 69 used two sessions, with the investigators grading photographs of the eyebrow and of the submental and neck area at 3 and 6 months. [[1]](https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211483.pdf) [[4]](https://pubmed.ncbi.nlm.nih.gov/38031530/) ### Who was studied, and when fat is the concern The 2026 study enrolled adults who wanted to improve facial wrinkles or lift lax skin. It excluded people with excessive subcutaneous facial fat, along with pronounced scarring, severe acne, pregnancy or breastfeeding, any history of smoking, recent isotretinoin or anticoagulant use and earlier invasive procedures in the treatment zones. Its 42 participants were aged 35 to 67 (mean 50.0), 40 were women, and their Fitzpatrick skin types were III (13) or IV (29). [[2]](https://pubmed.ncbi.nlm.nih.gov/42226470/) Figure: Two panels. K211483: 80 treated of 92 enrolled at 5 US sites, three zones per person, 467 facial areas. Chung 2026: 42 Asian adults aged 35 to 67, 40 women and 2 men, skin type III 13 and IV 29, with a list of exclusions starting with excessive subcutaneous facial fat. Who the neck results come from. Sources: [FDA K211483](https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211483.pdf); [Chung et al.](https://pubmed.ncbi.nlm.nih.gov/42226470/), sections 2.2 and 3.1. In a 2026 review, patient selection for ultrasonic facial rejuvenation centres on mild to moderate skin laxity. [[3]](https://pubmed.ncbi.nlm.nih.gov/41985490/) If the fullness under your chin is mostly fat, ask which other options fit that concern; [candidates and contraindications](https://sofwave-seoul.com/candidates-and-contraindications/) covers screening factors. ### Pain and the first days The mean pain level during treatment was 5.3 out of 10 for Zone 3 in the K211483 study. [[1]](https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211483.pdf) In the 2026 study, a 4% lidocaine cream was applied under cling film for 45 minutes beforehand, the mean pain score for the whole treatment was 5.06 out of 10, and 3 of 42 people needed paracetamol. Right after treatment, trace or slight redness was seen in 21 of 42 and trace or slight swelling in 3; all had resolved by the later visits. [[2]](https://pubmed.ncbi.nlm.nih.gov/42226470/) For the days after, see [aftercare and downtime](https://sofwave-seoul.com/aftercare-downtime/). ### Questions for a neck consultation - Is the change I want tighter skin, or less fullness under the chin? - Which zones will be treated, with how many passes and how much overlap? - When will the result be judged, and is there a check at 6 or 9 months? [Delight Dermatology Clinic’s Sofwave treatment page](https://hifuseoul.com/procedures/sofwave-seoul/) describes its treatment protocol. ### Common questions ### Does Sofwave work on the neck and under the chin? In the study summarized in FDA record K211483, quantitative 2D imaging measured an average lift of 38 mm² of lax submental and neck tissue, masked reviewers identified the before and after photos correctly for 80% (60/75) of treated subjects, and 85% (61/72) were rated improved on the PGAIS at the 3-month visit. ### How long do Sofwave neck results last? In a 2026 study of 42 Asian adults treated once, assessors rated submental and neck laxity improved in 83.3% at 3 months, 71.4% at 6 months and 69.2% at 9 months. Satisfaction with the result was 64.3%, 57.2% and 38.5% at the same visits. ### Does Sofwave remove fat under the chin? Sofwave targets the mid-dermis at a depth of about 1.5 mm. The 2026 study excluded people with excessive subcutaneous facial fat, and K211483 reports its neck result as tissue lift measured on 2D images. ### Does Sofwave help jowls? K211483 reports results for the brow and for the submental and neck zone, and the 2026 study gave PGAIS ratings for the brow, facial wrinkles and submental and neck laxity; neither gives a separate jowl or jawline rating. ### Does Sofwave on the neck hurt? In the K211483 study, the mean pain level during treatment was 5.3 out of 10 for the submental and neck zone. The 2026 study applied a 4% lidocaine cream for 45 minutes beforehand. ### Sources 1. [US FDA. K211483, SofWave System: letter dated November 15, 2021 and 510(k) summary. Comparison table on summary page 4, clinical study on pages 5–6.](https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211483.pdf) 2. [Chung MMH, Wong CSM, Chan MWM, Shek SYN, Yeung CK, Chan HHL. Evaluating the use of high-intensity non-focused ultrasound treatment to improve skin laxity and facial wrinkles in Asian patients. Lasers in Surgery and Medicine, 2026. PMID 42226470. Study funding: Sofwave Medical Ltd.](https://pubmed.ncbi.nlm.nih.gov/42226470/) 3. [Liao D, Prasad A, Bloom JD. Use of ultrasound in face and neck rejuvenation. Facial Plastic Surgery, 2026. PMID 41985490. Review.](https://pubmed.ncbi.nlm.nih.gov/41985490/) 4. [Gold MH, Biron J. Efficacy and safety of high-intensity, high-frequency, non-focused ultrasound parallel beams for facial skin laxity. Journal of Cosmetic Dermatology, 2024. PMID 38031530.](https://pubmed.ncbi.nlm.nih.gov/38031530/) ## Sofwave for upper arms: sessions, timing and FDA evidence Source: https://sofwave-seoul.com/sofwave-upper-arms/ Updated: 2026-10-18 FDA 510(k) K233104 added improvement of the appearance of upper-arm skin laxity to the SofWave System's US indications. The clinical study summarized in that record used **two sessions, 1–3 weeks apart**, and assessed the primary result three months after the final session. Figure: Teal wave lines cross seven translucent sea-foam cylinders on a white background. ### What K233104 actually documents The FDA's 510(k) summary identifies the added indication as improvement of the appearance of upper-arm skin laxity. The decision date is December 22, 2023. Protocol details recorded in FDA K233104 | Question | What the record says | | --- | --- | | Indication | Appearance of upper-arm skin laxity | | Study schedule | Two sessions, 1–3 weeks apart | | Primary assessment | Three months after the final session | ### How many Sofwave sessions are needed for upper arms? The study used two sessions, 1–3 weeks apart. At a consultation, ask how the proposed number of sessions and interval relate to your treatment area. Check whether a quote covers one session or the full proposed plan. For a broader description of the technology, see [how Sofwave works](https://sofwave-seoul.com/what-is-sofwave/). For screening factors, see [candidates and contraindications](https://sofwave-seoul.com/candidates-and-contraindications/). ### Follow-up timing The primary assessment took place three months after the second session. ### What to ask at a consultation If you are considering upper-arm treatment in Seoul, ask about local authorization, device availability and the evidence supporting the proposed plan. - Which indication and treatment area support the proposed schedule? - Is the quote per session, and how many sessions are being proposed? - When will the response be assessed, and what would count as a meaningful change? - Which risks, exclusions and alternatives apply to the upper-arm area? - Which device and treatment settings will be used? ### Frequently asked questions ### Is Sofwave FDA cleared for upper-arm skin laxity? Yes. FDA K233104 lists improvement of the appearance of upper-arm skin laxity as the added indication. ### How many sessions were used in the upper-arm study? The clinical study summarized in K233104 used two treatment sessions, scheduled 1–3 weeks apart. Ask which evidence and treatment area support the schedule proposed for you. ### When was the upper-arm result assessed? The primary follow-up described in the 510(k) summary was three months after the final treatment. This timing is measured from the second session, not from the first. ### Can the upper-arm schedule be applied to the face or neck? Session count and assessment timing depend on the treatment area and indication. The K233104 protocol applies to upper-arm skin laxity. ### Primary source 1. US Food and Drug Administration. [K233104 510(k) summary for the SofWave System](https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233104.pdf). Decision date December 22, 2023; indication on page 4 and clinical study schedule on pages 7–8. ## Sofwave vs Ultherapy: where the two devices diverge Source: https://sofwave-seoul.com/sofwave-vs-ultherapy/ Updated: 2026-10-18 **Sofwave and Ultherapy are both ultrasound devices, but they differ in beam geometry and in how many tissue planes they can reach.** Sofwave uses seven synchronized, non-focused beams to create separate cylindrical thermal zones in the dermis, centered approximately 1.5 mm deep. Ultherapy uses microfocused ultrasound with visualization (MFU-V) to place discrete thermal coagulation points at selectable focal depths of 1.5, 3.0 and 4.5 mm, with the deepest setting able to reach the SMAS, and it images the tissue in real time before each line is delivered. Both share the 1.5 mm plane. A [small randomized split-body trial](https://pubmed.ncbi.nlm.nih.gov/41025649/) compared Sofwave and Ultherapy for upper-inner-arm laxity. Its findings should not be generalized to facial or neck treatment. Figure: Left: equal-length bars ending on one flat shared line. Right: three aligned diamond markers at three different depths One fixed plane on the left, three selectable depths on the right. ### The difference in one picture Almost everything else follows from where each device deposits energy. The diagram below is drawn to scale on a 0–5 mm axis and holds every other variable constant. Figure: Where each ultrasound modality deposits energy, on a 0–5 mm depth scale. Skin cross-section on a 0–5 mm scale. Seven synchronized non-focused Sofwave beams create separate cylindrical thermal zones extending roughly 0.5–2 mm deep, centered at a target treatment depth of about 1.5 mm in the dermis. Ultherapy creates microfocused points at selectable depths of 1.5, 3.0 and 4.5 mm; the deepest setting can reach the SMAS. - Sofwave (SUPERB): seven separate cylindrical thermal zones; target treatment depth ≈1.5 mm, depth range ≈0.5–2 mm - Ultherapy (MFU-V): microfocused points at selectable 1.5, 3.0 and 4.5 mm - Epidermis 0–0.2 mm - Papillary dermis 0.2–1 mm - Reticular dermis 1–3 mm - Subcutaneous fat 3–4.4 mm - SMAS ≈4.5 mm Facial skin thickness varies by site and person. Both devices can treat at about 1.5 mm; device selection also depends on the clinical findings. ### Side by side Sofwave and Ultherapy compared on beam geometry, treatment depth, imaging, typical session length and cleared indications | Aspect | Sofwave (SUPERB) | Ultherapy (MFU-V) | | --- | --- | --- | | Beam geometry | Seven synchronized, non-focused beams create seven separate cylindrical thermal zones in the dermis | Microfocused beam concentrated to discrete thermal coagulation points along a line | | Treatment depth | Target treatment depth ≈1.5 mm; thermal zones ≈0.5–2 mm | Selectable transducers at 1.5, 3.0 and 4.5 mm | | Deepest plane reached | Mid-dermis. Does not reach the SMAS | The 4.5 mm transducer can reach the SMAS | | Imaging | No imaging. Contact cooling plus a real-time skin-temperature monitor | Real-time ultrasound visualization of the tissue plane before delivery | | Frequency | 10–12 MHz as reported in the peer-reviewed series | Device-dependent; lower frequency than Sofwave, consistent with deeper focus | | Typical session | About 30–60 minutes depending on areas treated | Varies by transducer combination and area; commonly longer for full face and neck | | Evidence base | Smaller: mostly single-arm series of 14–36 subjects with follow-up to 6–10 months | Larger and older, with more published follow-up across more indications | | Head-to-head trial | A small randomized split-body trial compared Sofwave and Ultherapy for upper-inner-arm laxity. Its findings should not be generalized to facial or neck treatment. | A small randomized split-body trial compared Sofwave and Ultherapy for upper-inner-arm laxity. Its findings should not be generalized to facial or neck treatment. | ### Why depth is the decisive variable Skin laxity is not one problem. Textural laxity (crepey skin, loss of firmness, fine lines) is largely a dermal issue, and a device that heats the dermis is addressing it directly. Descent of the deeper support structures is a different problem living in a different plane, and heating the dermis does not fix it. A 2026 review of ultrasound in face and neck rejuvenation frames the two technologies exactly this way: MFU-V targets the deep dermis and SMAS at 1.5 to 4.5 mm, while SUPERB delivers at a fixed 1.5 mm to target the mid-dermis, and both are described as suited to mild-to-moderate laxity. The practical implication is unglamorous. If the examination finds the problem is dermal, a fixed mid-dermal device is well matched to it. If the examination finds significant deeper descent, a device that cannot reach that plane will under-deliver no matter how many passes are used, and the honest options are a deeper modality or a surgical consultation. ### What the imaging difference means Ultherapy's visualization lets the operator confirm the tissue plane and see structures before each line is delivered, which matters most when energy is being placed deep: near bone, near nerve, in areas of variable fat thickness. Sofwave delivers at a shallow fixed depth and manages surface safety with cooling and temperature monitoring instead. Neither approach is a shortcut: they are answers to different risk profiles created by different depths. ### Comfort The published Sofwave series report mean pain scores of roughly 3.9 to 6.6 on a 0–10 scale depending on the protocol and the area treated. That is a real range, and the upper end is uncomfortable. Ultherapy is also described as painful by many patients. The small upper-arm comparison does not establish relative pain for face or neck treatment. What can be said is that comfort is protocol-dependent, that topical anesthetic is standard, and that pain tolerance is worth raising at the consultation rather than discovering mid-session. ### Can they be combined? They occupy overlapping planes at 1.5 mm, so combination is not a matter of stacking two treatments that never meet. Whether combining or sequencing them is appropriate, and with what interval, is a clinical judgment made at examination, based on where the laxity actually is and what the skin has already been through. ### Where radiofrequency fits Monopolar radiofrequency heats the dermis through a different physical mechanism from ultrasound. ### How the choice gets made at examination At examination the clinician assesses where the laxity sits, skin thickness and quality, prior treatments and injectables in the area, and what the patient is actually asking for. A device is then matched to that finding. A Sofwave treatment protocol is on [Delight Dermatology Clinic’s Sofwave treatment page](https://hifuseoul.com/procedures/sofwave-seoul/), and screening factors are listed on the [candidates page](https://sofwave-seoul.com/candidates-and-contraindications/). ### Published references 1. Loyal J, Hartman N, Goldman MP. A Single-Center, Blinded, Split-Body, Randomized Clinical Trial of High-Intensity, Parallel Ultrasound Beams Versus Microfocused Ultrasound With Visualization for the Treatment of Upper Inner Arm Skin Laxity. *Dermatologic Surgery*. 2026;52(4):349–354. [PubMed](https://pubmed.ncbi.nlm.nih.gov/41025649/) · doi:10.1097/DSS.0000000000004881 2. Liao D, Prasad A, Bloom JD. Use of ultrasound in face and neck rejuvenation. *Facial Plastic Surgery*. 2026 (online ahead of print). [PubMed](https://pubmed.ncbi.nlm.nih.gov/41985490/) · doi:10.1055/a-2854-6601 3. Wong A, Lowery AS, Bloom JD. Ultrasound therapy for the skin. *Facial Plastic Surgery Clinics of North America*. 2023;31(4):503–510. [PubMed](https://pubmed.ncbi.nlm.nih.gov/37806683/) · doi:10.1016/j.fsc.2023.05.008 4. Gold MH, Biron J. Efficacy and safety of high-intensity, high-frequency, non-focused ultrasound parallel beams for facial skin laxity. *Journal of Cosmetic Dermatology*. 2024;23(1):117–123. [PubMed](https://pubmed.ncbi.nlm.nih.gov/38031530/) · doi:10.1111/jocd.16098 5. Hongcharu W, Boonchoo K, Gold MH. The efficacy and safety of the high-intensity parallel beam ultrasound device at the depth of 1.5 mm for skin tightening. *Journal of Cosmetic Dermatology*. 2023;22(5):1488–1494. [PubMed](https://pubmed.ncbi.nlm.nih.gov/36757157/) · doi:10.1111/jocd.15672 ## What is Sofwave? The technology, stated plainly Source: https://sofwave-seoul.com/what-is-sofwave/ Updated: 2026-10-18 **Sofwave** is a non-invasive ultrasound device built on SUPERB (Synchronous Ultrasound Parallel Beam) technology and manufactured by Sofwave Medical Ltd. Seven transducers sit in direct contact with the skin and fire simultaneously with each pulse, delivering high-frequency, non-focused ultrasound at 10–12 MHz to a target treatment depth of about 1.5 mm, the mid-dermis. Peer-reviewed reports describe thermal zones spanning roughly 0.5 to 2 mm and reaching about 60–70 °C, an integrated contact cooling system with a real-time skin-temperature monitor to protect the epidermis, and sessions of roughly 30 to 60 minutes. It is FDA-cleared for facial lines and wrinkles, for lifting the eyebrow and lax submental and neck tissue in adults aged 22 and over, for short-term improvement in the appearance of cellulite, for acne scars, and for upper-arm skin laxity. ### What the device does to tissue Ultrasound in aesthetic dermatology works by absorption: tissue converts acoustic energy into heat. Raise a small volume of dermis into the roughly 60–70 °C range and collagen denatures in a controlled way, which starts a wound-healing response: fibroblast activation, then new collagen and elastin over the following months. Every device in this category is a different answer to the same engineering question: how do you put that heat where you want it without injuring the skin surface on the way in? Here the heat comes from sound rather than light, and the [guide to ultrasound and laser energy](https://sofwave-seoul.com/is-sofwave-a-laser/) explains what that changes at a consultation. Seven synchronized, non-focused ultrasound beams create separate cylindrical thermal zones in the dermis, centered approximately 1.5 mm deep. The epidermis is not avoided by aiming around it; it is actively cooled from the contact surface while the beams pass through, with a temperature monitor watching the surface in real time. The consequence is that Sofwave has a single treatment plane rather than a set of selectable ones, which is the central fact to understand about it. Figure: Where each ultrasound modality deposits energy, on a 0–5 mm depth scale. Skin cross-section on a 0–5 mm scale. Seven synchronized non-focused Sofwave beams create separate cylindrical thermal zones extending roughly 0.5–2 mm deep, centered at a target treatment depth of about 1.5 mm in the dermis. Ultherapy creates microfocused points at selectable depths of 1.5, 3.0 and 4.5 mm; the deepest setting can reach the SMAS. - Sofwave (SUPERB): seven separate cylindrical thermal zones; target treatment depth ≈1.5 mm, depth range ≈0.5–2 mm - Ultherapy (MFU-V): microfocused points at selectable 1.5, 3.0 and 4.5 mm - Epidermis 0–0.2 mm - Papillary dermis 0.2–1 mm - Reticular dermis 1–3 mm - Subcutaneous fat 3–4.4 mm - SMAS ≈4.5 mm Facial skin thickness varies by site and person. Both devices can treat at about 1.5 mm; device selection also depends on the clinical findings. ### Where 1.5 mm sits, anatomically A target treatment depth of about 1.5 mm places the energy in the mid-dermis: below the epidermis and papillary dermis, within the reticular dermis where the bulk of structural collagen sits, and above the subcutaneous fat and the SMAS. A 2024 histopathology study of facial skin treated with the parallel-beam device confirmed the thermal effect was restricted to the dermal layer, with collagen remodeling documented at 1–3 mm from the epidermis and measurable increases in collagen and elastic fiber density at two months. A 2025 study using serial human biopsies out to ten months described continuing collagen, elastin and glycosaminoglycan changes across the whole follow-up period. Sofwave targets the dermis and is not a fat-reduction device. Reported biopsy studies found thermal injury confined to the dermis. ### Device parameters as reported in the literature Sofwave SUPERB device parameters as reported in the peer-reviewed literature | Parameter | Reported value | | --- | --- | | Energy type | Non-focused high-frequency ultrasound; seven synchronized beams form separate cylindrical thermal zones | | Frequency | 10–12 MHz | | Target depth | Target treatment depth about 1.5 mm (mid-dermis); separate thermal zones extend roughly 0.5–2 mm deep | | Thermal zone temperature | About 60–70 °C inside the treated zone | | Epidermal protection | Integrated contact cooling plus a real-time skin-temperature monitor | | Reported session length | About 30–60 minutes depending on the areas treated | | Manufacturer | Sofwave Medical Ltd., Israel | | US FDA clearances | Facial lines and wrinkles (2019); eyebrow lift and lifting lax submental and neck tissue, ages 22+ (2021); short-term improvement in the appearance of cellulite (2022); acne scars (2023); upper-arm skin laxity (2023) | ### What the FDA has and has not cleared The Sofwave system received its first US clearance in 2019 for improvement of facial lines and wrinkles. In November 2021 the FDA cleared additional indications for lifting the eyebrow and lifting lax submental and neck tissue in subjects aged 22 and older. Short-term improvement in the appearance of cellulite followed in December 2022, treatment of acne scars in August 2023, and improvement of the appearance of upper-arm skin laxity in December 2023. A 510(k) clearance is based on substantial equivalence to a legally marketed device for the specified indications. Figure: What the FDA has cleared, and when 1. 2019·09·09 K191421 Improvement of facial lines and wrinkles 2. 2021·11·15 K211483 Lifting the eyebrow, and lifting lax submental and neck tissue (ages 22+) 3. 2022·12·16 K223237 Short-term improvement in the appearance of cellulite 4. 2023·08·28 K231537 Treatment of acne scars 5. 2023·12·22 K233104 Improvement of the appearance of upper-arm skin laxity US FDA 510(k) clearances by indication. ### What the published evidence supports The clinical literature on this device is real but modest in size. A 2023 study of 36 participants measured nasolabial fold and marionette line depression volume with 3D imaging and found statistically significant reduction at one and three months, with no significant further change between those two visits and no adverse events reported. A 2023 prospective trial of 15 subjects aged 40–69 assessed eyebrow, submental and neck lifting after two sessions and found improvement in all treated areas that was stable at three and six months. A 2024 study of 34 patients using a directional treatment technique measured an average tissue contraction of about 1.9 mm at eight weeks, essentially unchanged at 24 weeks. A 2025 retrospective series of 14 Asian patients treated for acne scars in a single session reported significant reduction in scar depression volume with follow-up out to eight months. These are small, mostly single-arm studies with short follow-up, several of them in Asian skin types, and pain scores in them range from about 3.9 to 6.6 on a 0–10 scale, which is meaningfully uncomfortable for some people. The studies describe gradual changes in the treated tissue. ### How the treatment is delivered in practice After the examination and cleansing, the treatment areas are mapped and the handpiece is moved between treatment points in a planned sequence. The published protocols use pulse energies in the region of 3.0–4.2 J with two to three passes per area, and around 150–200 pulses to cover both cheeks; the specific plan is set at examination. Most patients describe brief heat with each pulse. Topical anesthetic is commonly used. A treatment protocol is described on [Delight Dermatology Clinic’s Sofwave treatment page](https://hifuseoul.com/procedures/sofwave-seoul/). ### Reasonable expectations about timing Early tightness may reflect transient tissue responses, including thermal contraction and swelling. Assess sustained improvement over subsequent months. The change the studies measure appears over weeks to months as new collagen is laid down, which is why the two-to-three-month visit is the meaningful assessment point and why re-treatment is a decision made by examination rather than by a calendar interval. The [aftercare page](https://sofwave-seoul.com/aftercare-downtime/) sets out that timeline in detail. ### Published references 1. Hongcharu W, Boonchoo K, Gold MH. The efficacy and safety of the high-intensity parallel beam ultrasound device at the depth of 1.5 mm for skin tightening. *Journal of Cosmetic Dermatology*. 2023;22(5):1488–1494. [PubMed](https://pubmed.ncbi.nlm.nih.gov/36757157/) · doi:10.1111/jocd.15672 2. Gold MH, Biron J. Efficacy and safety of high-intensity, high-frequency, non-focused ultrasound parallel beams for facial skin laxity. *Journal of Cosmetic Dermatology*. 2024;23(1):117–123. [PubMed](https://pubmed.ncbi.nlm.nih.gov/38031530/) · doi:10.1111/jocd.16098 3. Suh DH, Lee SJ, Song KY, Ahn HJ, Shin MK. High-intensity, parallel ultrasound tightening of facial skin: clinical and pathologic results. *Journal of Cosmetic Dermatology*. 2025;24(2):e16670. [PubMed](https://pubmed.ncbi.nlm.nih.gov/39530193/) · doi:10.1111/jocd.16670 4. Carruthers J, Benitez Roig V, McDaniel DH, Jackson B, Bedich O, Amir R, Eckhouse S. Synchronous parallel ultrasound induces long-term extracellular matrix remodeling of human skin. *Dermatologic Surgery*. 2025;51(9S):S58–S64. [PubMed](https://pubmed.ncbi.nlm.nih.gov/41405933/) · doi:10.1097/DSS.0000000000004793 · Author group includes employees of the device manufacturer. 5. Boonchoo K, Hongcharu W. The efficacy and safety of a single treatment of high-intensity, high-frequency, non-focused ultrasound parallel beams for facial acne scars in Asian patients: a preliminary study. *Journal of Cosmetic Dermatology*. 2025;24(4):e70134. [PubMed](https://pubmed.ncbi.nlm.nih.gov/40132902/) · doi:10.1111/jocd.70134 6. Oku K. Vectorized facial skin tightening: a study on the Thermal Thread Technique utilizing high-intensity, high-frequency, parallel ultrasound beam. *Lasers in Surgery and Medicine*. 2024;56(4):355–360. [PubMed](https://pubmed.ncbi.nlm.nih.gov/38411259/) · doi:10.1002/lsm.23771