# K252189: LED Light Therapy Mask (2311, 2344, 2457, 2458)

- Pathway: 510(k) (Traditional)
- Applicant: Dongguan Yanxi Technology Co., Ltd.
- Decided: Sep 12, 2025 after 60 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). 188 ancestors in all.
No later device cites it as a predicate yet.
0 of 189 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251042: Light Therapy System (M500, L6), Guangzhou Ahead Intelligent Technology Co., Ltd. (2025) Summary page 5.
- K230351: LED Facial Mask, Shenzhen Sungpo Hi-Tech Electronic Co., Ltd. (2023) Summary page 5.
- K243040: LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418), Shenzhen Siken 3D Technology Development Co., Ltd. (2024) Summary page 5.

## Indications for use
Red light: Treatment of full-face wrinkles(suitable for model 2344 and model 2457). Amber light: Treatment of full-face wrinkles. Blue light: Treatment of mild to moderate inflammatory acne. Red+Infrared Light: Treatment of full-face wrinkles.

Source page: https://510kreport.com/device/K252189
Methodology: https://510kreport.com/methodology