510(k) K925124 ยท GEX Powered Laser Surgical Instrument
TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASE SYST
| Applicant | Trimedyne, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Mar 1, 1994 |
| Received | Oct 13, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K925124
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.