510(k) K223540 ยท GEX Powered Laser Surgical Instrument
AvalancheLase Family
| Applicant | Fotona D.O.O., Ljubljana, SI |
| Decision | Substantially Equivalent, Jan 19, 2023 |
| Received | Nov 25, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223540
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.