510(k) K950661 ยท GEX Powered Laser Surgical Instrument
CANDELA 10MM CIRCULAR SPOT LASER HANDPIECE
| Applicant | Candela Laser Corp., Wayland MA, US |
| Decision | Substantially Equivalent, Mar 10, 1995 |
| Received | Feb 13, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950661
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.