# K250966: CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.
- Decided: Jun 25, 2025 after 86 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: 16 generations back to K943450 (1995). 97 ancestors in all.
No later device cites it as a predicate yet.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221946: LED Light Therapy Mask (model: MK66R-B), Light Tree Ventures Europe B.V. (2022) Summary page 6.

## Indications for use
The CurrentBody Skin™ LED Light Therapy Mask Series 2 (Model: MK-90H) is an over-the-counter device that is intended for the use in the treatment of full-face wrinkles.

Source page: https://510kreport.com/device/K250966
Methodology: https://510kreport.com/methodology