510(k) K001676 ยท GEX Powered Laser Surgical Instrument
OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-A
| Applicant | Trimedyne, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Nov 2, 2000 |
| Received | Jun 1, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001676
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.