510(k) K121580 ยท GEX Powered Laser Surgical Instrument
SURELASE CO2 LASER SYSTEM
| Applicant | Clinicon Corp., Stanwood WA, US |
| Decision | Substantially Equivalent, Sep 25, 2012 |
| Received | May 30, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121580
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.