510(k) K972767 ยท GEX Powered Laser Surgical Instrument
CANDELA GENTLELASE GL DERMATOLOGICAL VASCULAR LESION LASER
| Applicant | Candela Corp., Wayland MA, US |
| Decision | Substantially Equivalent, Dec 4, 1997 |
| Received | Jul 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972767
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2013 | Candela Corporation Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015.
and Candela Laser GentleLase Pro LE,
Model number: 9914-00-9040 Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.