510(k) K011092 ยท GEX Powered Laser Surgical Instrument
CANDELA SPTL-1E PULSED DYE LASER
| Applicant | Candela Corp., Wayland MA, US |
| Decision | Substantially Equivalent, Jul 9, 2001 |
| Received | Apr 10, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011092
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.