510(k) K091169 ยท GEX Powered Laser Surgical Instrument
ELITE MPX LASER SYSTEM WITH CRYO C
| Applicant | Cynosure, Inc., Wesford MA, US |
| Decision | Substantially Equivalent, May 13, 2009 |
| Received | Apr 22, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091169
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2014 | Cynosure, Inc. Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.