# K253073: LED Light Therapy Device (SG-FSM, SG-NK, SG-CT)

- Pathway: 510(k) (Traditional)
- Applicant: Sunglor Technology Co., Ltd.
- Decided: Nov 19, 2025 after 57 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). 187 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 189 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241857: LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293), Dongguan Boyuan Intelligent Technology Co.,Ltd (2024) Summary page 6.
- K242382: décoLITE LED Device, iSMART Developments, Ltd. (2024) Summary page 6.
- K223544: LED light therapy mask (FM-01, FM-02, FM-03), Guangdong Newdermo Biotech Co., Ltd. (2023) Summary page 6.

## Most influential descendants
- K261052: LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) (2026), 0 descendants of its own

## Indications for use
The Led Light Therapy Device (Model:SG-FSM) is an Over-the-Counter medical device intended for treatment of wrinkles in the face and decolletage area. Red light: Treatment of wrinkles. Red+Infrared Light: Treatment of wrinkles. Amber light: Treatment of wrinkles. Amber+Infrared Light: Treatment of wrinkles. The Led Light Therapy Device (Model:SG-NK) is an Over-the-Counter medical device intended for treatment of wrinkles in the decolletage area. Red light: Treatment of wrinkles. Red+Infrared Light: Treatment of wrinkles. Amber light: Treatment of wrinkles. Amber+Infrared Light: Treatment of wrinkles. The Led Light Therapy Device (Model:SG-CT) is an Over-the-Counter medical device intended for treatment of wrinkles in the decolletage area. Red light: Treatment of wrinkles. Red+Infrared light: Treatment of wrinkles. Infrared light: Provide topical heating for the purpose of elevating tissue temperature, and to temporarily increase local blood circulation.

Source page: https://510kreport.com/device/K253073
Methodology: https://510kreport.com/methodology