# K253712: LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Rainbow Technology Co., Ltd.
- Decided: Jan 23, 2026 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). 197 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 199 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 5.

## Most influential descendants
- K261407: XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445) (2026), 0 descendants of its own

## Indications for use
*Red+Infrared light: Treatment of full-face wrinkles. *Red light: Treatment of full-face wrinkles. *Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm;relieving stiffness; promoting the relaxation of muscle tissue; 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. 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/K253712
Methodology: https://510kreport.com/methodology