510(k) K031140 ยท GEX Powered Laser Surgical Instrument
WATERLASE
| Applicant | Biolase Technology, Inc., Clemente CA, US |
| Decision | Substantially Equivalent, Jul 7, 2004 |
| Received | Apr 10, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031140
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 15, 2005 | Biolase Technology Inc Waterlase MD, dental laser unit, Model #6200218, serial numbers 10500210 to 105202680, inclusive. Terminated |
LYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.