# K250581: KALA Red Light Face Mask (KALA-01)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.
- Decided: May 30, 2025 after 92 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: 20 generations back to K943450 (1995). 194 ancestors in all.
No later device cites it as a predicate yet.
0 of 195 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221775: LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003), Light Tree Ventures Europe B.V. (2022) Summary page 6.
- K241857: LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293), Dongguan Boyuan Intelligent Technology Co.,Ltd (2024) Summary page 6.

## Indications for use
The KALA Red Light Face Mask (Model: KALA-01) is an over-the-counter device that is intended to emit energy in the red and near-infrared spectrum and is intended for the use in the treatment of full-face wrinkles. The KALA Red Light Face Mask (Model: KALA-01) is an over-the-counter device that is intended to emit energy in the blue region of the light spectrum and is intended for the use in the treatment of mild to moderate acne vulgaris of the face.

Source page: https://510kreport.com/device/K250581
Methodology: https://510kreport.com/methodology