510(k) K221712 ยท GEX Powered Laser Surgical Instrument
Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)
| Applicant | Fotona D.O.O., Ljubljana, SI |
| Decision | Substantially Equivalent, Oct 12, 2022 |
| Received | Jun 13, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221712
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.