510(k) K002308 ยท GEX Powered Laser Surgical Instrument
OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A
| Applicant | Trimedyne, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Dec 20, 2000 |
| Received | Jul 28, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002308
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.