510(k) K212492 ยท GEX Powered Laser Surgical Instrument
Frax 1940 for Nordlys and Frax Pro
| Applicant | Candela Corporation, Marlborough MA, US |
| Decision | Substantially Equivalent, Dec 20, 2021 |
| Received | Aug 9, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212492
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.