510(k) K081589 ยท GEX Powered Laser Surgical Instrument
WATERLASE, VERSION 3.0
| Applicant | Biolase Technology, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jun 13, 2008 |
| Received | Jun 5, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081589
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.