LED light therapy mask (FM-01, FM-02, FM-03) (K223544)
Description
LED light therapy mask (FM-01, FM-02, FM-03) by Guangdong Newdermo Biotech Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223544
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. LED light therapy mask (FM-01, FM-02, FM-03) (K223544) cites 5 predicate devices and is itself cited by 11 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222751 | LED Light Therapy Device, KN-7000L | Xuzhou Kernel Medical Equipment Co.... | 2023 |
| K221151 | Beauty LED Mask, Model: KFB265 | Hunan Guangye Biotechnology Co., Ltd. | 2022 |
| K212155 | TheraFace LED | Theragun, Inc. | 2021 |
| K200983 | Infrared light therapy led facial light therapy mask-Derma ... | Ningbo Hesi Electric Co., Ltd. | 2021 |
| K162489 | RED Light Device | Zhongshan Bisen Plastic Electronic ... | 2017 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K253874 | LED Therapy Light (COB1400, HP1800PRO) | Shenzhen Hanhua Opto Co., Ltd. | 2026 |
| K251012 | TRUDERMAL Pro (ZLD-390) | Shenzhen Kaiyan Medical Equipment C... | 2025 |
| K251667 | LED Light Therapy Mask (M01, M02, M06, M07, M08, M09) | Shenzhen Liyoutong Technology Co., ... | 2025 |
| K243978 | LED Facial Mask | Shenzhen Sunsred Technology Co.,Ltd | 2025 |
| K251042 | Light Therapy System (M500, L6) | Guangzhou Ahead Intelligent Technol... | 2025 |
| K242385 | LED Therapy Mask (MN1, M226) | Shenzhen Borria Technology Co., Ltd. | 2025 |
| K243555 | LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C,... | Shenzhen Eyco Technology Co., Ltd. | 2025 |
| K243423 | LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, R... | Shenzhen Rainbow Technology Co., Ltd. | 2025 |
| K243492 | Ulike Reglow Light Therapy Device (UM10) | Shenzhen Ulike Smart Electronics Co... | 2025 |
| K242638 | LED Light Therapy Machine (G1, G3, G4, G6) | Shenzhen Walton Technology Co., Ltd. | 2024 |
| K241857 | LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) | Dongguan Boyuan Intelligent Technol... | 2024 |
Trace the full predicate network for K223544
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.