# K241933: HIGHERDOSE Red and Infrared Light Mask (MK66-L)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.
- Decided: Sep 27, 2024 after 87 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: 18 generations back to K943450 (1995). 173 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 175 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.
- K214103: Shani Darden LED light therapy mask, Harpar Grace International (2022) Summary page 6.
- K191629: faceLITE, Ismart Marketing Svcs, Ltd. (2019) Summary page 7.
- K202390: Aduro Light Beauty Mask, Shenzhen Kaiyan Medical CO, Ltd. (2021) Summary page 7.

## Most influential descendants
- K260150: Led Facial Mask (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) (2026), 0 descendants of its own

## Indications for use
The HIGHERDOSE Red And Infrared Light Mask (Model: MK66-L) 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/K241933
Methodology: https://510kreport.com/methodology