510(k) K011041 ยท GEX Powered Laser Surgical Instrument
WATERLASE, MILLENNIUM
| Applicant | Biolase Technology, Inc., Clemente CA, US |
| Decision | Substantially Equivalent, Jul 3, 2001 |
| Received | Apr 5, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011041
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.