510(k) K013043 ยท GEX Powered Laser Surgical Instrument
CANDELA CLEARBEAM PULSED DYE LASER
| Applicant | Candela Corp., Wayland MA, US |
| Decision | Substantially Equivalent, Oct 11, 2001 |
| Received | Sep 10, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013043
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.