510(k) K003385 ยท GEX Powered Laser Surgical Instrument
TWILITE, TWILITE WHITE
| Applicant | Biolase Technology, Inc., Clemente CA, US |
| Decision | Substantially Equivalent, Jan 25, 2001 |
| Received | Oct 31, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003385
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.