510(k) K163638 ยท GEX Powered Laser Surgical Instrument
Dental 5 Multi Diode laser
| Applicant | Bio-Med USA, Inc., Paterson NJ, US |
| Decision | Substantially Equivalent, May 15, 2017 |
| Received | Dec 23, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163638
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.