# K243978: LED Facial Mask

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Sunsred Technology Co.,Ltd
- Decided: Jun 20, 2025 after 179 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.
No later device cites it as a predicate yet.
0 of 175 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 6.

## Indications for use
The LED Facial Mask is an over-the-counter (OTC) device intended for the following uses: For Red Mode(s): The device emits energy in the red spectrum and is intended for the treatment of full-face wrinkles. For Red + NIR Mode: The device emits energy in the red and infrared spectrum and is intended for the treatment of full-face wrinkles. For Blue Mode: The device emits light in the blue region of the spectrum and is specifically indicated for the treatment of mild to moderate acne on the face. For NIR Mode: The device is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.

Source page: https://510kreport.com/device/K243978
Methodology: https://510kreport.com/methodology