LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) (K241857)
Description
LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) by Dongguan Boyuan Intelligent Technology Co.,Ltd, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241857
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 Device (KFB290, KFB291, KFB265, KFB293) (K241857) cites 4 predicate devices and is itself cited by 4 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230351 | LED Facial Mask | Shenzhen Sungpo Hi-Tech Electronic ... | 2023 |
| K223544 | LED light therapy mask (FM-01, FM-02, FM-03) | Guangdong Newdermo Biotech Co., Ltd. | 2023 |
| K221151 | Beauty LED Mask, Model: KFB265 | Hunan Guangye Biotechnology Co., Ltd. | 2022 |
| K162489 | RED Light Device | Zhongshan Bisen Plastic Electronic ... | 2017 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251588 | LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-... | Shenzhen Fittop Health Technology C... | 2025 |
| K251667 | LED Light Therapy Mask (M01, M02, M06, M07, M08, M09) | Shenzhen Liyoutong Technology Co., ... | 2025 |
| K250581 | KALA Red Light Face Mask (KALA-01) | Shenzhen Kaiyan Medical Equipment C... | 2025 |
| 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 K241857
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.