510(k) K892516 ยท GEX Powered Laser Surgical Instrument
CANDELA PLDL-1 PULSED DYE LASER
| Applicant | Candela Laser Corp., Wayland MA, US |
| Decision | Substantially Equivalent, Jun 15, 1989 |
| Received | Apr 11, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K892516
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.