# K253054: LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.
- Decided: Dec 19, 2025 after 88 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). 320 ancestors in all.
No later device cites it as a predicate yet.
0 of 321 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 5.
- 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 5.
- K243492: Ulike Reglow Light Therapy Device (UM10), Shenzhen Ulike Smart Electronics Co., Ltd. (2025) Summary page 6.
- K223544: LED light therapy mask (FM-01, FM-02, FM-03), Guangdong Newdermo Biotech Co., Ltd. (2023) Summary page 6.

## Indications for use
The device is an over the counter device that is intended for: Red+Infrared light: Treatment of full-face wrinkles; Red+Blue+Infrared light: Treatment of mild to moderate inflammatory acne; Yellow+Infrared light: Treatment of full-face wrinkles.

Source page: https://510kreport.com/device/K253054
Methodology: https://510kreport.com/methodology