510(k) K992574 ยท GEX Powered Laser Surgical Instrument
OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500A
| Applicant | Trimedyne, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Oct 29, 1999 |
| Received | Aug 2, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992574
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.