Class Class II
LED Facial Mask (K230351)
Description
LED Facial Mask by Shenzhen Sungpo Hi-Tech Electronic Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230351
Clearance Date2023-05-05
Clearance TypeTraditional
Product CodeOHS
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230351
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 Facial Mask (K230351) cites 3 predicate devices and is itself cited by 6 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220168 | Skin Care Beauty Mask (Model: MJ-06) | Shenzhen Kaiyan Medical CO , Ltd. | 2022 |
| K203271 | Aduro light therapy Handheld | Shenzhen Kaiyan Medical CO , Ltd. | 2021 |
| K190443 | MMSphere | Galactic Beauty, LLC | 2019 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K260767 | Facial Beauty Device (Facial Mask LED Beauty Device A-901; ... | Kam Yuen Plastic Products , Ltd. | 2026 |
| K251588 | LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-... | Shenzhen Fittop Health Technology C... | 2025 |
| K251042 | Light Therapy System (M500, L6) | Guangzhou Ahead Intelligent Technol... | 2025 |
| K243423 | LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, R... | Shenzhen Rainbow Technology Co., Ltd. | 2025 |
| K243040 | LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-19... | Shenzhen Siken 3D Technology Develo... | 2024 |
| K241857 | LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) | Dongguan Boyuan Intelligent Technol... | 2024 |
Trace the full predicate network for K230351
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.