# K252319: Q-Switched Nd: YAG Laser machine (LFS-C13U)

- Pathway: 510(k) (Traditional)
- Applicant: Sanhe Lefis Electronics Co., Ltd.
- Decided: Oct 20, 2025 after 87 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: 15 generations back to K910422 (1992). 135 ancestors in all.
No later device cites it as a predicate yet.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193609: Q Switched Nd: YAG Laser machine, Beijing Lead Beauty S & T Co., Ltd. (2020) Summary page 7.
- K173038: CuRAS Nd:YAG Laser, Ilooda Co,., Ltd. (2017) Summary page 7.

## Indications for use
The Q-Switched Nd: YAG Laser machine 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/K252319
Methodology: https://510kreport.com/methodology