510(k) K894977 ยท GEX Powered Laser Surgical Instrument
OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM
| Applicant | Trimedyne, Inc., Tustin CA, US |
| Decision | Substantially Equivalent, Oct 10, 1989 |
| Received | Aug 7, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894977
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.