510(k) K083733 ยท GEX Powered Laser Surgical Instrument
LUME 2 SYSTEM, MODEL GA0005000
| Applicant | Lumenis, Ltd., Salt Lake City UT, US |
| Decision | Substantially Equivalent, May 4, 2009 |
| Received | Dec 16, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083733
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.