510(k) K190319 ยท GEX Powered Laser Surgical Instrument
Waterlase Laser System Family
| Applicant | Biolase, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Oct 10, 2019 |
| Received | Feb 13, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190319
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.