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..

Summary

Xuzhou Kernel Medical Equipment's Uv Phototherapy comes in three models: KN-4001A, KN-4001B, and KN-4001AB. The record lists no product code, device class, or regulation number for it.

The classification panel is listed as Unknown, and the General and Plastic Surgery review panel handled it as a Traditional 510(k).

Xuzhou Kernel filed from Xuzhou, China. The decision came 53 calendar days after receipt (May 29 to July 21, 2026).

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 ↗

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