510(k) K043012 ยท GEX Powered Laser Surgical Instrument
OMNIPULSE MINI, MODEL 2120
| Applicant | Trimedyne, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Nov 17, 2004 |
| Received | Nov 2, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043012
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.