# K241857: LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)

- Pathway: 510(k) (Traditional)
- Applicant: Dongguan Boyuan Intelligent Technology Co.,Ltd
- Decided: Oct 11, 2024 after 106 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). 185 ancestors in all.
21 later devices descend from it; 9 cite it directly.
0 of 207 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223544: LED light therapy mask (FM-01, FM-02, FM-03), Guangdong Newdermo Biotech Co., Ltd. (2023) Summary page 5.
- K230351: LED Facial Mask, Shenzhen Sungpo Hi-Tech Electronic Co., Ltd. (2023) Summary page 5.
- K221151: Beauty LED Mask, Model: KFB265, Hunan Guangye Biotechnology Co., Ltd. (2022) Summary page 5.

## Most influential descendants
- K242700: Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B) (2024), 6 descendants of its own
- K243423: LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB) (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
- K253712: LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073) (2026), 1 descendant of its own
- K253073: LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) (2025), 1 descendant of its own

## Indications for use
KFB290, KFB291: Red light: Treatment of full-face wrinkles. Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. Red+Infrared Light: Treatment of full-face wrinkles. Amber light: Treatment of full-face wrinkles. Blue light: Treatment of mild to moderate inflammatory acne. Mixed light(Red+Blue +Infrared): Treatment of mild to moderate inflammatory acne. KFB265, KFB293: Red+Infrared Light: Treatment of wrinkles. Blue light: Treatment of mild to moderate inflammatory acne. Amber light: Treatment of wrinkles.

Source page: https://510kreport.com/device/K241857
Methodology: https://510kreport.com/methodology