Class Class II
LED Light Therapy Device, KN-7000L (K222751)
Description
LED Light Therapy Device, KN-7000L by Xuzhou Kernel Medical Equipment Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222751
Clearance Date2023-02-01
Clearance TypeTraditional
Product CodeGEX
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222751
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, KN-7000L (K222751) cites 2 predicate devices and is itself cited by 5 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200104 | Oxylight | Raja Trading Company, Inc. | 2020 |
| K190938 | Phototherapy System | Shanghai Apolo Medical Technology C... | 2019 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K243993 | Photon Therapy Apparatus (BL-10) | Xemis Medical Technology (Shenzhen)... | 2025 |
| K241293 | LED Light Therapy Device, ELIXIR MD | Yassen Wellness, LLC | 2024 |
| K233077 | FlashHeal 2 (FlashHeal 2.0) | Inwound Aps | 2024 |
| K230342 | Phototherapy System (OL-PDT950) | Shanghai Omni Laser Skinology Co., ... | 2023 |
| K223544 | LED light therapy mask (FM-01, FM-02, FM-03) | Guangdong Newdermo Biotech Co., Ltd. | 2023 |
Trace the full predicate network for K222751
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.