510(k) K030235 ยท GEX Powered Laser Surgical Instrument
F1 DIODE LASER SYSTEM
| Applicant | Opus Medical, Inc., Rockville MD, US |
| Decision | Substantially Equivalent, Apr 23, 2003 |
| Received | Jan 23, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030235
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.