510(k) K915117 ยท GEX Powered Laser Surgical Instrument
MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM
| Applicant | Trimedyne, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Apr 2, 1992 |
| Received | Nov 13, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915117
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.