Class Class II
LED LIGHT MASK (A093) (K250880)
Description
LED LIGHT MASK (A093) by Foshan Guangyu Weilai Medical Equipment Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250880
Clearance Date2025-06-20
Clearance TypeTraditional
Product CodeOHS
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250880
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 MASK (A093) (K250880) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243423 | LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, R... | Shenzhen Rainbow Technology Co., Ltd. | 2025 |
Trace the full predicate network for K250880
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.