510(k) K230460 ยท GEX Powered Laser Surgical Instrument
Laser Thermal Therapy Kit
| Applicant | Elesta S.P.A, Calenzano, IT |
| Decision | Substantially Equivalent, May 22, 2023 |
| Received | Feb 21, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230460
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.