510(k) K011174 ยท GEX Powered Laser Surgical Instrument
PARADIGM-FONTONA PEROVSKITE ND: YAP LASER SYSTEM AND ACCESSORIES
| Applicant | Fotona D.D., Ljubljana, SI |
| Decision | Substantially Equivalent, Nov 7, 2001 |
| Received | Apr 17, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011174
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.