510(k) K192430 ยท GEX Powered Laser Surgical Instrument
Epic 980
| Applicant | Biolase, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Dec 4, 2019 |
| Received | Sep 5, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192430
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.