510(k) K101658 ยท GEX Powered Laser Surgical Instrument
WATERLASE MD TURBO PLUS MODEL 7200XXX
| Applicant | Biolase Technology, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Aug 11, 2010 |
| Received | Jun 11, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101658
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2014 | Biolase Technology Inc WaterLase iPlus Dental Laser System, Part No. 7200854-XX
Software Upgrade Kit, Part No. 6201463. Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.