# K140249: Long Pulse ND: Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Technology Laser Co., Ltd.
- Decided: Oct 8, 2014 after 250 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: 7 generations back to K910422 (1992). 37 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022923: Candela Gentle Yag Laser System, Candela Corp. (2003) Summary page 5.

## Most influential descendants
- K202288: Finebeam (2021), 2 descendants of its own
- K260256: Q-Switched Nd: YAG Laser Systems (2026), 0 descendants of its own
- K243780: HELIOS 785 Pico (1754V2) (2025), 0 descendants of its own

## Indications for use
Long pulse Nd:YAG Laser System is intended for use for : • Benign pigmented lesions such as ,but not limited to , lemtigos( age spots), solar lentigos( sun spots), café au lait macules, seborrheic karatoses, nevi, chloasma, verrucae, skin tags, karatoses, tattoss( significant reduction in the intensity of black and/or blue black tattoos) and plaques. • Pigmented lesions to reduce lesion size, for patients with lesions that would potientlly 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/K140249
Methodology: https://510kreport.com/methodology