# K133158: ND: Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Toplaser Technology Co., Ltd.
- Decided: Feb 28, 2014 after 134 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: 1 generation back to K011677 (2001). 2 ancestors in all.
5 later devices descend from it; 1 cites 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)
- K014234: Medlite IV Q-Switchednd: Yaglaser Replaced by the Medlite C6 Q-Swicthed ND: Yag Laser, Continuum Electro-Optics, Inc. (2002) Summary page 1.
- K011677: Medlite Q-Switched ND:Yag Laser Replaced by the Medlite C3 Q-Swtiched ND:Yag Laser, Continuum Electro-Optics, Inc. (2001) Summary page 1.

## Most influential descendants
- K163123: Q-Switched Nd:YAG Laser Therapy Systems (2017), 4 descendants of its own
- 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
* Tattoo Removal * Treatment of Vascular Lesions * Treatment of Pigmented Lesions, * Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology 1064nm 532nm Tattoo Removal Tattoo Removal * Dark ink: blue and black 6 Light Ink: red * Light ink: sky blue and green Treatment of Pigmented Lesions Treatment of Vascular Lesions * Nevus of ota * Port wine birthmarks * Telangiectasias * Spider angioma * Cherry angioma * Spider nevi Treatment of Pigmented Lesions * Caf&-au-Iait birthmarks * Solar lentiginos * Senile lentiginos " Becker's nevi * Freckles * Nevus spilus

Source page: https://510kreport.com/device/K133158
Methodology: https://510kreport.com/methodology