510(k) K964818 ยท GEX Powered Laser Surgical Instrument
ORION SERIES SURGICAL LASER SYSTEM (Q-SWITCHED ND:YAG CONFIGURATION)
| Applicant | Laserscope, San Jose CA, US |
| Decision | Substantially Equivalent, Jun 17, 1997 |
| Received | Nov 29, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964818
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.