510(k) K970422 ยท GEX Powered Laser Surgical Instrument
RIGHT ANGLE LASER FIBERS;OPTILASE ND:YAG LASER;OPTILASE PL100 ND LASER SYSTEMS
| Applicant | Trimedyne, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Apr 21, 1997 |
| Received | Feb 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970422
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.