510(k) K122368 ยท GEX Powered Laser Surgical Instrument
WATERLASE IPLUS ALL TISSUE LASER
| Applicant | Biolase Technology, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, May 2, 2013 |
| Received | Aug 6, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122368
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.