# K250880: Led Light Mask (A093)

- Pathway: 510(k) (Traditional)
- Applicant: Foshan Guangyu Weilai Medical Equipment Co., Ltd.
- Decided: Jun 20, 2025 after 88 days
- Product code: OHS (Light Based Over The Counter Wrinkle Reduction)
- 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: 21 generations back to K943450 (1995). 197 ancestors in all.
No later device cites it as a predicate yet.
0 of 198 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243423: LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB), Shenzhen Rainbow Technology Co., Ltd. (2025) Summary page 6.

## Indications for use
- Red light: Treatment of full-face wrinkles. - Blue light: Treatment of mild to moderate inflammatory acne. - Red+Blue light: Treatment of mild to moderate inflammatory acne.The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne for adults in home healthcare environment.

Source page: https://510kreport.com/device/K250880
Methodology: https://510kreport.com/methodology