510(k) K151109 ยท GEX Powered Laser Surgical Instrument
Lumenis Smart532 Laser System
| Applicant | Lumenis, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Oct 30, 2015 |
| Received | Apr 27, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151109
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.