# K253400: LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Saidi Light Therapy Technology Co., Ltd.
- Decided: Dec 24, 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: 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 5.

## Indications for use
a. Red light: Treatment of full-face wrinkles. b. 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. c. Amber light: Treatment of full-face wrinkles. d. Blue light: Treatment of mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K253400
Methodology: https://510kreport.com/methodology