Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)
FDA 510(k) K261775 · Xuzhou Kernel Medical Equipment Co., Ltd.
510(k) numberK261775
Submission
- Device name
- Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)
- Applicant
- Xuzhou Kernel Medical Equipment Co., Ltd.
Xuzhou, CN - Received
- May 29, 2026
- Decision date
- July 21, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
No product code recorded.
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|---|---|---|
| K242977 | 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…FTC · Traditional | 02/06/2025SE |
| K222751 | LED Light Therapy Device, KN-7000LGEX · Traditional | 02/01/2023SE |
| K200971 | 308nm Excimer SystemFTC · Traditional | 12/15/2020SE |
| K200929 | Hair Growth SystemOAP · Traditional | 06/03/2020SE |
| K190685 | Hair Growth SystemOAP · Traditional | 07/26/2019SE |
| K181805 | UV PhototherapyFTC · Traditional | 01/11/2019SE |
| K160341 | Colposcope SystemHEX · Traditional | 09/14/2016SE |
| K132643 | UV PhototherapyFTC · Traditional | 01/30/2014SE |
Questions and answers
When was Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB) cleared by the FDA?
Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB) (K261775) received a 510(k) decision of Substantially Equivalent on July 21, 2026, 53 days after the submission was received.