# K250936: Q-Switched Nd:YAG Laser (SHE-LSP101-1)

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Sano Laser S&T Development Co.,Ltd
- Decided: Jun 12, 2025 after 76 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: 17 generations back to K943450 (1995). 251 ancestors in all.
No later device cites it as a predicate yet.
0 of 252 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123293: Pastelle Q-Switched ND: Yag Laser, Won Technology Co., Ltd. (2013) Summary page 5.
- K014234: Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6 Q-Swicthed ND: Yag Laser, Continuum Electro-Optics, Inc. (2002) Summary page 5.

## Indications for use
The Q-Swithched Nd:YAG Laser 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 for General Dermatology, Dermatologic and General Surgical Procedures as follows: 1064nm: -Tattoo removal dark ink: blue and black -Treatment of Benign Pigmented Lesions Nevus of ota 532nm: -Tattoo removal Light ink: red, 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/K250936
Methodology: https://510kreport.com/methodology