# K024260: Candela Gentlelase Family of Laser Systems

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Mar 21, 2003 after 88 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- 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.
186 later devices descend from it; 6 cite it directly.
0 of 201 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
- K042474: ARION (2004), 114 descendants of its own
- K073534: Candela Family of Q-Switched Alexandrite Laser (Alexlazr) Systems (2008), 113 descendants of its own
- K081352: Profile Multi-Platform System (2008), 112 descendants of its own
- K081324: Candela Family of Q-Switched Alexandrite Lasers (2008), 112 descendants of its own

## Recalls of this device
- Nov 6, 2013 · Class II · Z-0348-2014: Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury.

## Indications for use
1. Temporary hair reduction. 2. Stable long-term, or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. 3. On all skin types (Fitzpatrick I-VI) including tanned skin.

Source page: https://510kreport.com/device/K024260
Methodology: https://510kreport.com/methodology