510(k) K001589 ยท GEX Powered Laser Surgical Instrument
CANDELA DYNAMIC COOLING DEVICE
| Applicant | Candela Corp., Wayland MA, US |
| Decision | Substantially Equivalent, Aug 18, 2000 |
| Received | May 23, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001589
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.