510(k) K202991 ยท GEX Powered Laser Surgical Instrument
Fotona XPulse Pro Laser Platform
| Applicant | Fotona D.O.O., Ljubljana, SI |
| Decision | Substantially Equivalent, Jun 22, 2021 |
| Received | Sep 30, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202991
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.