510(k) K101783 ยท GEX Powered Laser Surgical Instrument
COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE
| Applicant | New Star Lasers, Inc., Roseville CA, US |
| Decision | Substantially Equivalent, Sep 13, 2010 |
| Received | Jun 25, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101783
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.