FDA 510(k)

Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)

K-Number: K261775 · 2026-07-21

ApplicantXuzhou Kernel Medical Equipment Co., Ltd.

Decision Date2026-07-21

Product Code

DecisionSubstantially Equivalent

Device Summary

Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB) is the device name listed in this FDA 510(k) record. The listed applicant is Xuzhou Kernel Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2026-07-21 under 510(k) number K261775. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)?

Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB) is a medical device that received FDA 510(k) clearance on 2026-07-21. The listed applicant is Xuzhou Kernel Medical Equipment Co., Ltd.. The 510(k) number is K261775.

When did Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB) receive FDA 510(k) clearance?

Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB) received FDA 510(k) clearance on 2026-07-21, under 510(k) number K261775.

Who is the listed applicant for Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)?

The FDA 510(k) record lists Xuzhou Kernel Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

Other records listing Xuzhou Kernel Medical Equipment Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.