# K260715: CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)

- Pathway: 510(k) (Traditional)
- Applicant: The Beauty Tech Group, Ltd.
- Decided: Jun 3, 2026 after 90 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: 21 generations back to K943450 (1995). 350 ancestors in all.
No later device cites it as a predicate yet.
0 of 351 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251588: LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910), Shenzhen Fittop Health Technology Co., Ltd. (2025) Summary page 7.
- K242593: CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N), Shenzhen Kaiyan Medical Equipment Co., Ltd. (2025) Summary page 7.
- K260129: Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ), Shenzhen Kaiyan Medical Equipment Co., Ltd. (2026). Cleared while this submission was under review Summary page 7.

## Indications for use
The CurrentBody Skin™ LED Multi Light Therapy Mask is an over-the-counter, non-invasive light therapy device. The CurrentBody Skin™ LED Multi Light Therapy Mask delivers visible and near-infrared (NIR) light to the face via non-coherent light-emitting diodes (LEDs). The mask provides four selectable treatment modes: Mode 1 (including red (633nm), NIR (830nm & 1072nm)) is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. Mode 2 (including blue (415nm) & red (633nm)) is intended for the treatment of mild to moderate inflammatory acne. Mode 3 (including yellow (590nm) & NIR (830nm)) is intended for the treatment of full face wrinkles. The device is intended for use on Fitzpatrick skin types I-IV.

Source page: https://510kreport.com/device/K260715
Methodology: https://510kreport.com/methodology