# K063072: Candela Family of Q-Switched Alexandrite Laser (Alexlazr) Systems: 532 and 1064 ND:Yag Handpiece Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Dec 20, 2006 after 75 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: 1 generation back to K942152 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011677: Medlite Q-Switched ND:Yag Laser Replaced by the Medlite C3 Q-Swtiched ND:Yag Laser, Continuum Electro-Optics, Inc. (2001)
- K942152: Candela Q-Switched, Frequency Doubled ND;Yag Laser SY, Candela Laser Corp. (1994) Summary page 1.
- K955662: Candela Q-Switched Alexandrite Lasers, Candela Laser Corp. (1996) Summary page 1.

## Indications for use
The Candela Family of Q-Switched Alexandrite Laser (AleXLAZR) systems: 532 and 1064 Nd:YAG Handpiece Accessories are indicated for the following uses: Tattoo Removal Treatment of Vascular Lesions Treatment of Pigmented Lesions Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology

Source page: https://510kreport.com/device/K063072
Methodology: https://510kreport.com/methodology