Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)— 510(k) K261775

Name: FDA 510(k) clearance K261775
Creator: U.S. Food and Drug Administration
Published: 2026-07-21

Substantially Equivalent

Xuzhou Kernel Medical Equipment Co., Ltd.

FDA 510(k) clearance K261775 for Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB), Substantially Equivalent on 2026-07-21. Applicant: Xuzhou Kernel Medical Equipment Co., Ltd..

Clearance details

Applicant: Xuzhou Kernel Medical Equipment Co., Ltd.
Advisory panel: Unknown
Date received: 2026-05-29
Decision date: 2026-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xuzhou, CN

Download summary PDF View on FDA.gov ↗

More clearances from Xuzhou Kernel Medical Equipment Co., Ltd.

view all

K242977 — 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)2025-02-06
K222751 — LED Light Therapy Device, KN-7000L2023-02-01
K200971 — 308nm Excimer System2020-12-15
K200929 — Hair Growth System2020-06-03
K190685 — Hair Growth System2019-07-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.