# K163123: Q-Switched Nd:YAG Laser Therapy Systems

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Sincoheren Science and Technology Development Co.
- Decided: Feb 2, 2017 after 86 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: 2 generations back to K011677 (2001). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133158: ND: Yag Laser System, Beijing Toplaser Technology Co., Ltd. (2014) Summary page 5.

## Most influential descendants
- K193609: Q Switched Nd: YAG Laser machine (2020), 2 descendants of its own
- K261841: Q Switched Nd:YAG Laser machine (QLQW-01) (2026), 0 descendants of its own
- K252319: Q-Switched Nd: YAG Laser machine (LFS-C13U) (2025), 0 descendants of its own
- K242943: Q Switched Nd:YAG Laser machine (QNHF-01) (2025), 0 descendants of its own

## Indications for use
The Q-Switched Nd: YAG Laser Therapy System (1064nm or 532nm) is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology as follows: 1064nm: -Tattoo Removal Dark ink: blue and black. -Treatment of Benign Pigmented Lesions Nevus of ota. 532nm: -Tattoo Removal Light ink: red. Light ink: sky blue and green. - Treatment of Benign Vascular Lesions Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi. -Treatment of Benign Pigmented Lesions Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.

Source page: https://510kreport.com/device/K163123
Methodology: https://510kreport.com/methodology