510(k) K101601 ยท GEX Powered Laser Surgical Instrument
AFFIRM DO DIODE LASER
| Applicant | Cynosure, Inc., Wesford MA, US |
| Decision | Substantially Equivalent, Sep 23, 2010 |
| Received | Jun 8, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101601
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.