# K260946: LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Newdermo Biotech Co., Ltd.
- Decided: Jun 18, 2026 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: 19 generations back to K943450 (1995). 189 ancestors in all.
No later device cites it as a predicate yet.
0 of 190 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 7.
- K251012: TRUDERMAL Pro (ZLD-390), Shenzhen Kaiyan Medical Equipment Co., Ltd. (2025) Summary page 7.

## Indications for use
The LED Light Therapy Mask adopts the latest LED light therapy technology, combining 6 kinds of Model: K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K. The LED Light Therapy Mask (Model: K9C-TK) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne. 1.Deep Red and Infrared light (660nm + 850nm): Intended for treatment of wrinkles. 2.Red light and Near-Infrared light (630nm + 830nm): Intended for treatment of wrinkles. 3.Amber light(605nm): Intended for treatment of wrinkles. 4. Blue light and Red light (415nm + 630nm): Intended for treatment of mild to moderate inflammatory acne. 5.Blue light(415nm): Intended for treatment of mild to moderate inflammatory acne. The LED Light Therapy Mask (Models:K9C-K, K9P-YK, K9P-K) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne. 1.Deep Red and Infrared light (660nm + 850nm): Intended for treatment of wrinkles. 2.Red light and Near-Infrared light (630nm + 830nm): Intended for treatment of wrinkles. 3.Blue light and Red light (415nm + 630nm): Intended for treatment of mild to moderate inflammatory acne. 4.Blue light(415nm): Intended for treatment of mild to moderate inflammatory acne. The LED Light Therapy Mask(Model: FM-03BK) is an Over-the-Counter (OTC) device intended for treatment of wrinkles. 1.Red light (630nm): Intended for treatment of wrinkles. 2.Red light and Near-Infrared light (630nm + 830nm): Intended for treatment of wrinkles. The LED Light Therapy Mask (Model: FM-09K) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne. 1.Red light (630nm): Intended for treatment of wrinkles. 2.Red light and Near-Infrared light (630nm + 830nm): Intended for treatment of wrinkles. 3.Blue light and Red light (415nm + 630nm): Intended for treatment of mild to moderate inflammatory acne. 4.Blue light(415nm): Intended for treatment of mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K260946
Methodology: https://510kreport.com/methodology