510(k) K004021 ยท GEX Powered Laser Surgical Instrument
F1 DIODE LASER SYSTEM
| Applicant | Opus Medical, Inc., Albuquerque, NM, US |
| Decision | Substantially Equivalent, Mar 27, 2001 |
| Received | Dec 27, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K004021
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.