510(k) K001527 ยท GEX Powered Laser Surgical Instrument
FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIES
| Applicant | Fotona D.D., Ljubljana, SI |
| Decision | Substantially Equivalent, Jul 27, 2000 |
| Received | May 16, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001527
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.