# K024371: Candela Gentle Lase Family of Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Mar 31, 2003 after 90 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: 5 generations back to K963094 (1996). 14 ancestors in all.
207 later devices descend from it; 6 cite it directly.
0 of 222 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994260: Candela Gentlelase GL Dermatological Laser, Candela Corp. (2000) Summary page 1.

## Most influential descendants
- K063074: Candela 3630 Laser System (2006), 179 descendants of its own
- K043251: Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1B (2005), 136 descendants of its own
- K050673: Candela Family of Pulse Dye Laser Systems (2005), 133 descendants of its own
- K070388: Profile Multi-Platform System (2007), 129 descendants of its own
- K073534: Candela Family of Q-Switched Alexandrite Laser (Alexlazr) Systems (2008), 113 descendants of its own

## Indications for use
Treatment of benign pigmented lesions

Source page: https://510kreport.com/device/K024371
Methodology: https://510kreport.com/methodology