HIGHERDOSE Red and Infrared Light Mask (MK66-L) (K241933)
Description
HIGHERDOSE Red and Infrared Light Mask (MK66-L) by Shenzhen Kaiyan Medical Equipment Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241933
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. HIGHERDOSE Red and Infrared Light Mask (MK66-L) (K241933) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221775 | LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-... | Light Tree Ventures Europe B.V. | 2022 |
| K214103 | Shani Darden LED light therapy mask | Harpar Grace International | 2022 |
| K202390 | Aduro Light Beauty Mask | Shenzhen Kaiyan Medical CO , Ltd. | 2021 |
| K191629 | faceLITE | Ismart Marketing Svcs, Ltd. | 2019 |
Trace the full predicate network for K241933
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.