510(k) K934865 ยท GEX Powered Laser Surgical Instrument
OMNIPULSE MODEL 1210-VHP HO:YAG LASER SYSTEM
| Applicant | Trimedyne, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, May 12, 1994 |
| Received | Oct 12, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934865
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.