510(k) K992298 ยท GEX Powered Laser Surgical Instrument
IRIDERM, MODEL APEX 800
| Applicant | Iridex Corp, Mountain View CA, US |
| Decision | Substantially Equivalent, Dec 9, 1999 |
| Received | Jul 8, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992298
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.