510(k) K051359 ยท GEX Powered Laser Surgical Instrument
CANDELA FAMILY OF PULSED DYE LASER SYSTEMS: PIGMENTED LESION HANDPIECE ACCESSORY
| Applicant | Candela Corp., Wayland MA, US |
| Decision | Substantially Equivalent, Jul 13, 2005 |
| Received | May 24, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051359
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.