LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) (K251588)
Description
LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) by Shenzhen Fittop Health Technology Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251588
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 (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) (K251588) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242593 | CurrentBody LED 4 in 1 Zone Facial Mapping Mask (MK-90C, M... | Shenzhen Kaiyan Medical Equipment C... | 2025 |
| K242796 | CryoGlow (FW3XXXX) | Sharkninja Operating, LLC | 2024 |
| K241857 | LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) | Dongguan Boyuan Intelligent Technol... | 2024 |
| K230351 | LED Facial Mask | Shenzhen Sungpo Hi-Tech Electronic ... | 2023 |
| K230042 | Q-Rejuvalight Pro Facewear (Model: P19-0023) | Light Tree Ventures Europe B.V. | 2023 |
Trace the full predicate network for K251588
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.