# K022923: Candela Gentle Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Candela Corp.
- Decided: Mar 13, 2003 after 190 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: 6 generations back to K910422 (1992). 36 ancestors in all.
656 later devices descend from it; 2 cite it directly.
0 of 693 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010104: Candela Long Pulse ND:Yag, Candela Corp. (2001)
- K014040: Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and Future Models, Altus Medical, Inc. (2002) Summary page 1.

## Most influential descendants
- K033172: Candela Gentleyag Family of Laser Systems (2003), 654 descendants of its own
- K042000: Modified MSQ Family of Lovely Light/Laser Systems (2004), 517 descendants of its own
- K040617: Reliant Laser System II (2004), 316 descendants of its own
- K042319: Reliant Laser II System and Accessories (2005), 284 descendants of its own
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own

## Indications for use
The Candela GentleYAG Laser is intended for use for: Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue black tattoos) and plaques. Pigmented lesioiis to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

Source page: https://510kreport.com/device/K022923
Methodology: https://510kreport.com/methodology