510(k) K080006 ยท GEX Powered Laser Surgical Instrument
AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE
| Applicant | Cynosure, Inc., Wesford MA, US |
| Decision | Substantially Equivalent, Feb 28, 2008 |
| Received | Jan 2, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080006
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.