510(k) K220853 ยท GEX Powered Laser Surgical Instrument
PicoWay Laser System
| Applicant | Candela Corporation, Marlborough MA, US |
| Decision | Substantially Equivalent, Oct 13, 2022 |
| Received | Mar 23, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220853
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.