510(k) K081181 ยท GEX Powered Laser Surgical Instrument
SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULSE) SURGICAL LASER
| Applicant | Cynosure, Inc., Wesford MA, US |
| Decision | Substantially Equivalent, May 5, 2008 |
| Received | Apr 25, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081181
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.