# K251042: Light Therapy System (M500, L6)

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Ahead Intelligent Technology Co., Ltd.
- Decided: Jun 6, 2025 after 64 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). 186 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 188 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K223544: LED light therapy mask (FM-01, FM-02, FM-03), Guangdong Newdermo Biotech Co., Ltd. (2023) Summary page 5.
- K171323: Biophotas CELLUMA3, Biophotas, Inc. (2017) Summary page 5.
- K200983: Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine, Ningbo Hesi Electric Co., Ltd. (2021) Summary page 5.
- K241718: Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W), Shenzhen Aozemei Technology Co., Ltd. (2024) Summary page 5.

## Most influential descendants
- K252189: LED Light Therapy Mask (2311, 2344, 2457, 2458) (2025), 0 descendants of its own

## Indications for use
Blue light: Treatment of mild to moderate inflammatory acne. Red+IR light: Treatment of facial wrinkles. Amber light: Treatment of facial wrinkles. Mixed light: Treatment of mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K251042
Methodology: https://510kreport.com/methodology