510(k) K951562 ยท GEX Powered Laser Surgical Instrument
OMNIPULSE-MAX HOLMIUM LASER
| Applicant | Trimedyne, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jul 21, 1995 |
| Received | Apr 4, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951562
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.