510(k) K252155 · ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
AVAVA Skin Treatment System
| Applicant | AVAVA, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Oct 20, 2025 |
| Received | Jul 9, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252155
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.