510(k) K152032 ยท GEX Powered Laser Surgical Instrument
ELUMI 810 + 980 Soft Tissue Laser
| Applicant | Azena Medical, LLC, Pleasant Hill CA, US |
| Decision | Substantially Equivalent, Sep 16, 2015 |
| Received | Jul 22, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152032
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.