# K242943: Q Switched Nd:YAG Laser machine (QNHF-01)

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Nubway S&T Co., Ltd.
- Decided: Mar 3, 2025 after 159 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: 3 generations back to K011677 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163123: Q-Switched Nd:YAG Laser Therapy Systems, Beijing Sincoheren Science and Technology Development Co. (2017) Summary page 5.

## Indications for use
The Q Switched Nd:YAG Laser machine (QNHF-01) 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/K242943
Methodology: https://510kreport.com/methodology