510(k) K161669 ยท GEX Powered Laser Surgical Instrument
Waterlase Express
| Applicant | Biolase, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jul 28, 2016 |
| Received | Jun 16, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161669
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.