510(k) K014128 ยท GEX Powered Laser Surgical Instrument
CANDELA SMOOTHBEAM LASER SYSTEM
| Applicant | Candela Corp., Wayland MA, US |
| Decision | Substantially Equivalent, Oct 4, 2002 |
| Received | Dec 17, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K014128
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.