# K243423: LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Rainbow Technology Co., Ltd.
- Decided: Jan 28, 2025 after 85 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). 196 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 200 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.
- K230351: LED Facial Mask, Shenzhen Sungpo Hi-Tech Electronic Co., Ltd. (2023) Summary page 5.
- K241102: Luna 4 plus, Foreo, Inc. (2024) Summary page 5.
- K160691: Acne Light Therapy Wand, Zuko, Inc. (2016) Summary page 5.
- K223544: LED light therapy mask (FM-01, FM-02, FM-03), Guangdong Newdermo Biotech Co., Ltd. (2023) Summary page 5.

## Most influential descendants
- K253712: LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073) (2026), 1 descendant of its own
- 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
- K250880: Led Light Mask (A093) (2025), 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/K243423
Methodology: https://510kreport.com/methodology