# K260767: Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)

- Pathway: 510(k) (Traditional)
- Applicant: Kam Yuen Plastic Products, Ltd.
- Decided: Aug 31, 2026 after 175 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: 19 generations back to K943450 (1995). 198 ancestors in all.
No later device cites it as a predicate yet.
0 of 199 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230293: TheraFace Mask, Therabody, Inc. (2023) Summary page 6.
- K230351: LED Facial Mask, Shenzhen Sungpo Hi-Tech Electronic Co., Ltd. (2023) Summary page 6.
- K241102: Luna 4 plus, Foreo, Inc. (2024) Summary page 6.
- K243430: Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W), Shenzhen Aozemei Technology Co., Ltd. (2024) Summary page 6.

## Indications for use
Facial Mask LED Beauty Device A-901 is an over-the-counter device. The Red light mode is intended for the treatment of full face wrinkles. The Red and Infrared light combination mode is intended for the treatment of full-face wrinkles. The blue light mode is intended for the treatment of mild to moderate inflammatory acne. The device is indicated for adults only. Facial LED & EMS Beauty Device A-902 is an over-the-counter device. The Red light mode is intended for the treatment of facial wrinkles. The EMS mode is intended for facial stimulation. The Blue light mode is intended for the treatment of mild to moderate inflammatory acne. The device is indicated for adults only. Facial Mask LED & EMS Beauty Device A-907 is an over-the-counter device. The Red light mode is intended for the treatment of periorbital wrinkles. The EMS mode is intended for facial stimulation. The Blue light mode is intended for the treatment of mild to moderate inflammatory acne. The device is indicated for adults only. The devices are intended for use on Fitzpatrick skin types |, I, and Ill.

Source page: https://510kreport.com/device/K260767
Methodology: https://510kreport.com/methodology