# K261673: LED Therapy Device (QLXY-01)

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Nubway S&T Co., Ltd.
- Decided: Sep 17, 2026 after 119 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: 18 generations back to K943450 (1995). 239 ancestors in all.
No later device cites it as a predicate yet.
0 of 240 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202175: OxyLight 2.0, Raja Trading Company, Inc. (2021) Summary page 6.

## Indications for use
The LED Therapy Device is intended for: -Blue light: (460-465nm)- to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. -Red light: (620-625nm)-for treatment of superficial, benign vascular and pigmented lesions. -Yellow light: ( 585-590nm)-treatment of periorbital wrinkles and rhytides.

Source page: https://510kreport.com/device/K261673
Methodology: https://510kreport.com/methodology