# K261601: LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Chuangtong Yigou Technology Co., Ltd.
- Decided: Aug 7, 2026 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: 18 generations back to K943450 (1995). 175 ancestors in all.
No later device cites it as a predicate yet.
0 of 176 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242638: LED Light Therapy Machine (G1, G3, G4, G6), Shenzhen Walton Technology Co., Ltd. (2024) Summary page 6.

## Indications for use
The LED Light Therapy Mask is an over-the-counter (OTC) device intended for the following uses: For Red+NIR Mode: Treatment of full-face wrinkles. For Blue+Red+NIR mode: Treatment of mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K261601
Methodology: https://510kreport.com/methodology