Sofwave for acne scars: two studies, different protocols
Delight Dermatology editorial team · Published
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. Read their schedules and outcome measures separately before applying either result to a treatment plan. [1] [2]
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. This is a US regulatory record; it does not establish Korean authorization, a clinic's services, or what an individual will experience. [3] [4]
The multicenter study: read the score, not a promise
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]
The average acne-scar severity score fell from 2.31 to 1.26, a 45.5% reduction in that rating. It does not mean that every participant lost 45.5% of their scars, or that the same proportion of scar tissue was removed. The study also reported a blinded photograph-identification endpoint; that is a different measure from severity. [1]
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. A small retrospective series cannot establish that one session is sufficient for every scar pattern. [2]
| 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. These observations do not establish a risk-free treatment or reliably exclude rare complications. [1] [2]
Neither report supplies a randomized head-to-head comparison with other acne-scar procedures. Different endpoints and follow-up periods also prevent treating their numbers as a league table. The single-session report's authors declared no conflicts of interest; the PubMed abstract of the multicenter report is not a complete funding disclosure. Read the full study and its disclosures before treating the evidence as independent. [1] [2]
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 for the broader Sofwave context. Evidence for acne scars should not be substituted for evidence about upper-arm laxity or facial lifting comparisons.
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. These US records do not establish Korean authorization or availability at a particular clinic.
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. They do not establish one schedule for everyone.
Does the reported 45.5% reduction mean that nearly half of every scar disappears?
No. It describes the change in the prospective study’s average scar-severity rating, from 2.31 to 1.26. It is not a percentage of scar tissue removed or an individual result prediction.
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.