510(k) K002884 ยท GEX Powered Laser Surgical Instrument
PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES
| Applicant | Fotona D.D., Ljubljana, SI |
| Decision | Substantially Equivalent, Dec 4, 2000 |
| Received | Sep 15, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002884
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.