510(k) K980475 ยท GEX Powered Laser Surgical Instrument
UNIPULSE CO2 SURGICAL LASER SYSTEM
| Applicant | Nidek, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Dec 16, 1998 |
| Received | Feb 6, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980475
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.