510(k) K133895 ยท GEX Powered Laser Surgical Instrument
DEKA SMARTXIDE LASER SYSTEM
| Applicant | El.En S.P.A., Hopkinton MA, US |
| Decision | Substantially Equivalent, Sep 5, 2014 |
| Received | Dec 20, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133895
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.