510(k) K163128 ยท GEX Powered Laser Surgical Instrument
Epic Pro
| Applicant | Biolase, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jan 11, 2017 |
| Received | Nov 8, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163128
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.