510(k) K897157 ยท GEX Powered Laser Surgical Instrument
OPTILASE YAG MODEL 1000 ACV SURGICAL LASER SYSTEM
| Applicant | Trimedyne, Inc., Tustin CA, US |
| Decision | Substantially Equivalent, Feb 22, 1990 |
| Received | Dec 26, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K897157
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.