510(k) K221623 ยท GEX Powered Laser Surgical Instrument
FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm
| Applicant | Gme German Medical Engineering GmbH, Erlangen, DE |
| Decision | Substantially Equivalent, Mar 10, 2023 |
| Received | Jun 6, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221623
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.