Class Class II
KALA Red Light Face Mask (KALA-01) (K250581)
Description
KALA Red Light Face Mask (KALA-01) by Shenzhen Kaiyan Medical Equipment Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250581
Clearance Date2025-05-30
Clearance TypeTraditional
Product CodeOHS
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250581
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. KALA Red Light Face Mask (KALA-01) (K250581) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241857 | LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) | Dongguan Boyuan Intelligent Technol... | 2024 |
| K221775 | LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-... | Light Tree Ventures Europe B.V. | 2022 |
Trace the full predicate network for K250581
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.