# K251588: LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Fittop Health Technology Co., Ltd.
- Decided: Aug 21, 2025 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: 20 generations back to K943450 (1995). 318 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 321 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K241857: LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293), Dongguan Boyuan Intelligent Technology Co.,Ltd (2024) Summary page 6.
- K242796: CryoGlow (FW3XXXX), Sharkninja Operating, LLC (2024) Summary page 6.
- K230351: LED Facial Mask, Shenzhen Sungpo Hi-Tech Electronic Co., Ltd. (2023) Summary page 6.
- K230042: Q-Rejuvalight Pro Facewear (Model: P19-0023), Light Tree Ventures Europe B.V. (2023) Summary page 6.

## Most influential descendants
- K260715: CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) (2026), 0 descendants of its own
- K253054: LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) (2025), 0 descendants of its own

## Indications for use
The LED Light Therapy Mask (Model: FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne. FCM902, FCM905, FCM906, FCM908: a.Red light: Treatment of full-face wrinkles. b.Blue+Infrared light: Treatment of mild to moderate inflammatory acne. c.Yellow+Infrared light: Treatment of full-face wrinkles. 11-001-RBMASK: a.Red+Infrared light: Treatment of full-face wrinkles. b.Blue light: Treatment of mild to moderate inflammatory acne. FCM910: a.Red+Infrared light: Treatment of full-face wrinkles. b.Blue light: Treatment of mild to moderate inflammatory acne. c.Yellow+Infrared light: Treatment of full-face wrinkles.

Source page: https://510kreport.com/device/K251588
Methodology: https://510kreport.com/methodology