510(k) K213726 ยท GEX Powered Laser Surgical Instrument
PL-1 Skin Treatment System
| Applicant | AVAVA, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Jun 28, 2022 |
| Received | Nov 26, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213726
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.