510(k) K221268 ยท ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
SR-1 Skin Treatment System
| Applicant | AVAVA, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Nov 21, 2022 |
| Received | May 2, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221268
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.