# K251667: LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Liyoutong Technology Co., Ltd.
- Decided: Aug 7, 2025 after 69 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: 20 generations back to K943450 (1995). 186 ancestors in all.
No later device cites it as a predicate yet.
0 of 187 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241857: LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293), Dongguan Boyuan Intelligent Technology Co.,Ltd (2024) Summary page 5.
- K192295: PDT-Face, Beijing Adss Development Co., Ltd. (2020) Summary page 5.

## Indications for use
Red light: Treatment of full-face wrinkles. Red+Infrared Light: Treatment of full-face wrinkles. Amber light: Treatment of full-face wrinkles. Blue light: Treatment of mild to moderate inflammatory acne. Red+Infrared Light: Treatment of full-face wrinkles. Amber light: Treatment of full-face wrinkles. Mixed light: Treatment of mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K251667
Methodology: https://510kreport.com/methodology