510(k) K202258 ยท GEX Powered Laser Surgical Instrument
ERISE Laser handpiece
| Applicant | El.En Electronic Engineering Spa, Calenzano, IT |
| Decision | Substantially Equivalent, Apr 26, 2021 |
| Received | Aug 10, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202258
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.