510(k) K083215 ยท GEX Powered Laser Surgical Instrument
INCISIVE FAMILY OF INPULSE ND:YAG LASERS
| Applicant | Incisive, LLC, Pleasanton CA, US |
| Decision | Substantially Equivalent, Apr 8, 2009 |
| Received | Oct 31, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083215
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.