# K221946: LED Light Therapy Mask (model: MK66R-B)

- Pathway: 510(k) (Traditional)
- Applicant: Light Tree Ventures Europe B.V.
- Decided: Nov 22, 2022 after 140 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: 15 generations back to K943450 (1995). 96 ancestors in all.
18 later devices descend from it; 2 cite it directly.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191629: faceLITE, Ismart Marketing Svcs, Ltd. (2019) Summary page 5.

## Most influential descendants
- K240089: Face Patches (MT-12MA, MT-12MC) (2024), 16 descendants of its own
- K242700: Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B) (2024), 6 descendants of its own
- K242593: CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) (2025), 3 descendants of its own
- K243492: Ulike Reglow Light Therapy Device (UM10) (2025), 3 descendants of its own
- K251588: LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) (2025), 2 descendants of its own

## Indications for use
The LED Light Therapy Mask (Model:MK66R-B) 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/K221946
Methodology: https://510kreport.com/methodology