510(k) K050412 ยท GEX Powered Laser Surgical Instrument
VAPORMAX
| Applicant | Trimedyne, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Mar 14, 2005 |
| Received | Feb 18, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050412
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.