510(k) K043251 ยท GEX Powered Laser Surgical Instrument
CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B
| Applicant | Candela Corp., Wayland MA, US |
| Decision | Substantially Equivalent, Feb 9, 2005 |
| Received | Nov 23, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043251
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.