510(k) K922497 ยท GEX Powered Laser Surgical Instrument
OPTILASE ND:YAG MODELS 1000/4000 SURG LASER SYSTEM
| Applicant | Trimedyne, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Mar 1, 1994 |
| Received | May 27, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K922497
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.