510(k) K092964 ยท GEX Powered Laser Surgical Instrument
COOLTOUCH VARIA ND:YAG LASER SYSTEM
| Applicant | New Star Lasers, Inc., Roseville CA, US |
| Decision | Substantially Equivalent, Dec 11, 2009 |
| Received | Sep 25, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092964
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.