510(k) K990119 ยท GEX Powered Laser Surgical Instrument
EPI-STAR SURGICAL LASER SYSTER
| Applicant | Nidek, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Jul 27, 2000 |
| Received | Jan 13, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990119
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.