# K252093: Light Therapy Mask (1019055)

- Pathway: 510(k) (Traditional)
- Applicant: Merchsource, LLC
- Decided: Oct 16, 2025 after 105 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 6.

## Indications for use
The Light Therapy Mask is an over-the-counter device intended for the treatment of full-face wrinkles and mild to moderate inflammatory acne using LED light therapy. - Red light: Treatment of full-face wrinkles. - Blue light: Treatment of mild to moderate inflammatory acne. - Red+Infrared Light: Treatment of full-face wrinkles. - Mixed light (Red+Blue+Infrared): Treatment of mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K252093
Methodology: https://510kreport.com/methodology