# K214103: Shani Darden LED light therapy mask

- Pathway: 510(k) (Traditional)
- Applicant: Harpar Grace International
- Decided: Mar 22, 2022 after 83 days
- Product code: OLP (Over-The-Counter Powered Light Based Laser For Acne)
- 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). 113 ancestors in all.
19 later devices descend from it; 6 cite it directly.
0 of 133 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213184: MZ Skin LightMAX Supercharged LED Mask 2.0, Mz Skin (2021) Summary page 6.

## Most influential descendants
- K230124: LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001) (2023), 10 descendants of its own
- K230042: Q-Rejuvalight Pro Facewear (Model: P19-0023) (2023), 9 descendants of its own
- K221775: LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003) (2022), 7 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
- K251588: LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) (2025), 2 descendants of its own

## Indications for use
The Shani Darden LED light therapy mask 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 Shani Darden LED light therapy mask 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/K214103
Methodology: https://510kreport.com/methodology