510(k) K090618 ยท GEX Powered Laser Surgical Instrument
CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO C
| Applicant | Cynosure, Inc., Wesford MA, US |
| Decision | Substantially Equivalent, Apr 14, 2009 |
| Received | Mar 9, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090618
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.