# K242638: LED Light Therapy Machine (G1, G3, G4, G6)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Walton Technology Co., Ltd.
- Decided: Nov 27, 2024 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: 17 generations back to K943450 (1995). 174 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 176 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223544: LED light therapy mask (FM-01, FM-02, FM-03), Guangdong Newdermo Biotech Co., Ltd. (2023) Summary page 5.

## Most influential descendants
- K261601: LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) (2026), 0 descendants of its own

## Indications for use
Red light: Treatment of full-face wrinkles. Blue light: Treatment of mild to moderate inflammatory acne. 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. Mixed light: Treatment of mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K242638
Methodology: https://510kreport.com/methodology