510(k) K083927 ยท GEX Powered Laser Surgical Instrument
WATERLASE MD
| Applicant | Biolase Technology, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Oct 1, 2009 |
| Received | Dec 31, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083927
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.