# K261407: XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445)

- Pathway: 510(k) (Traditional)
- Applicant: Dongguan Miqiang Technology Co., Ltd.
- Decided: Jul 15, 2026 after 77 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: 22 generations back to K943450 (1995). 198 ancestors in all.
No later device cites it as a predicate yet.
0 of 199 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K253712: LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073), Shenzhen Rainbow Technology Co., Ltd. (2026) Summary page 6.

## Indications for use
XPREEN LED Light Therapy Masks are Over the Counter devices that are intended for the use in the treatment of full face wrinkles and treatment of mild to moderate inflammatory acne. Red light: Treatment of full-face wrinkles. Yellow light: Repair and reduce wrinkles. Infrared light: Provide topical heating for the purpose of elevating tissue temperature; and to temporarily increase local blood circulation. Blue light: Treatment of mild to moderate inflammatory acne. Red+Blue light: Treatment of mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K261407
Methodology: https://510kreport.com/methodology