# K063800: Candela Fluorescent Pulsed Light System

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Feb 5, 2007 after 45 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K910422 (1992). 61 ancestors in all.
No later device cites it as a predicate yet.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032191: Omnilight Fluorescent Pulsed Light System, Luxsano AB (2003) Summary page 1.
- K041086: Palomar Starlux Pulsed Light System, Palomar Medical Products, Inc. (2005) Summary page 1.

## Indications for use
The Candela Fluorescent Pulsed Light System is indicated for the following uses: Hair removal in all skin types to the Fitzpatrick scale. Permanent Hair Reduction. Treatment of Vascular Lesions Treatment of Inflammatory Acne (acne vulgaris) Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae.

Source page: https://510kreport.com/device/K063800
Methodology: https://510kreport.com/methodology