# K223544: LED light therapy mask (FM-01, FM-02, FM-03)

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Newdermo Biotech Co., Ltd.
- Decided: Feb 23, 2023 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: 16 generations back to K943450 (1995). 173 ancestors in all.
39 later devices descend from it; 13 cite it directly.
0 of 213 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K221151: Beauty LED Mask, Model: KFB265, Hunan Guangye Biotechnology Co., Ltd. (2022) Summary page 6.
- K162489: RED Light Device, Zhongshan Bisen Plastic Electronic Products Co., Ltd. (2017) Summary page 6.
- K212155: TheraFace LED, Theragun, Inc. (2021) Summary page 6.

## Most influential descendants
- K241857: LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) (2024), 21 descendants of its own
- 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
- K242385: LED Therapy Mask (MN1, M226) (2025), 3 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
- K243492: Ulike Reglow Light Therapy Device (UM10) (2025), 3 descendants of its own

## Indications for use
Red light: Treatment of full-face wrinkles. Blue light: Treatment of mild to moderate inflammatory acne. 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. Mixed light: Treatment of mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K223544
Methodology: https://510kreport.com/methodology