Class Class II
LED Facial Mask (K243978)
Description
LED Facial Mask by Shenzhen Sunsred Technology Co.,Ltd, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243978
Clearance Date2025-06-20
Clearance TypeTraditional
Product CodeOHS
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243978
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 Facial Mask (K243978) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223544 | LED light therapy mask (FM-01, FM-02, FM-03) | Guangdong Newdermo Biotech Co., Ltd. | 2023 |
| K162652 | Smart Photon Micro-current Device, Model: EP-300 | Li-Tek Electronic Technology Corpor... | 2017 |
| K163329 | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 | Pulsaderm, LLC | 2017 |
| K162489 | RED Light Device | Zhongshan Bisen Plastic Electronic ... | 2017 |
Trace the full predicate network for K243978
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.