510(k) K964353 ยท GEX Powered Laser Surgical Instrument
CYBERLASE CO2 LASER SYSTEM
| Applicant | Nidek, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Feb 28, 1997 |
| Received | Nov 1, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964353
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.