510(k) K210183 ยท GEX Powered Laser Surgical Instrument
Waterlase iPLus
| Applicant | Biolase, Inc., Foothill Ranch CA, US |
| Decision | Substantially Equivalent, Apr 21, 2022 |
| Received | Jan 25, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210183
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.