510(k) K050673 ยท GEX Powered Laser Surgical Instrument
CANDELA FAMILY OF PULSE DYE LASER SYSTEMS
| Applicant | Candela Corp., Wayland MA, US |
| Decision | Substantially Equivalent, Jun 13, 2005 |
| Received | Mar 15, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050673
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 15, 2007 | Candela Laser Corporation Candela Corporation Vbeam Aesthetica Laser System, Model/Catalog # 9914-00-0320 Vbeam Aesthetica w/ gray enclosure and rose colored display Terminated |
GEX | None listed |
| May 4, 2006 | Candela Laser Corporation Candela Laser VBeam Perfecta, a Pulsed Dye Laser used for General Surgery, Dermatology, Gynecology, Podiatry.
Model Number: 9914-00-0300 Terminated |
GXE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.