# K221775: LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)

- Pathway: 510(k) (Traditional)
- Applicant: Light Tree Ventures Europe B.V.
- Decided: Dec 20, 2022 after 182 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: 17 generations back to K943450 (1995). 114 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K214103: Shani Darden LED light therapy mask, Harpar Grace International (2022) Summary page 5.
- K191629: faceLITE, Ismart Marketing Svcs, Ltd. (2019) Summary page 5.

## Most influential descendants
- K251012: TRUDERMAL Pro (ZLD-390) (2025), 1 descendant of its own
- K241933: HIGHERDOSE Red and Infrared Light Mask (MK66-L) (2024), 1 descendant of its own
- K233114: LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200) (2024), 1 descendant of its own
- K260946: LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) (2026), 0 descendants of its own
- K260150: Led Facial Mask (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) (2026), 0 descendants of its own

## Indications for use
For MK-78, MK-04, The LED Light Therapy Mask (Models: MK-78, MK-04) is an over the counter device that is intended for the use in the treatment of full-face wrinkles. For MK66-H, EL00003 The LED Light Therapy Mask (Models: MK66-H, EL00003) is an over the counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The LED Light Therapy Mask (Models: MK66-H, EL00003) is an over the counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles.

Source page: https://510kreport.com/device/K221775
Methodology: https://510kreport.com/methodology