510(k) K161185 ยท GEX Powered Laser Surgical Instrument
LUCERNA Dental Laser
| Applicant | Viax Dental Lab, Alajuela, CR |
| Decision | Substantially Equivalent, Sep 26, 2016 |
| Received | Apr 27, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161185
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.