# K994260: Candela Gentlelase GL Dermatological Laser

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: May 26, 2000 after 161 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: 4 generations back to K963094 (1996). 13 ancestors in all.
258 later devices descend from it; 11 cite it directly.
0 of 272 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974381: Candela Gentlelase GL Dermatological Laser, Candela Corp. (1998) Summary page 1.
- K981351: Candela Gentlelase GL Dermatological Laser, Candela Corp. (1998) Summary page 1.
- K982940: Lightsheer Pulsed Diode Array Laser System, Star Medical Technologies, Inc. (1999) Summary page 1.
- K980517: Epilaser Normal Mode Ruby Laser, Palomar Medical Products, Inc. (1998) Summary page 1.
- K990903: Lyra Series Surgical System (SL Seriesq-Switched ND:Yag Configuration), Laserscope (1999) Summary page 1.

## Most influential descendants
- K024371: Candela Gentle Lase Family of Laser System (2003), 207 descendants of its own
- K024335: Candela Gentlelase Family of Laser Systems (2003), 187 descendants of its own
- K024260: Candela Gentlelase Family of Laser Systems (2003), 186 descendants of its own
- 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

## Indications for use
The Candela GentleLASE GL Dermatology Laser is indicated for the following uses: 1. The Photocoagulation of Dermatological vascular lesions. 2. Temporary hair reduction. 3. Stable long-term, or permanent hair reduction through selective targetlng 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. It is also intended for the photocoagulation of dermatological vascular lesions.

Source page: https://510kreport.com/device/K994260
Methodology: https://510kreport.com/methodology