FDA 510(k)

Ulikeクリアゼロ（YC10 BU）

K番号: K260895 · 2026-05-28

申請者Guangxi Ulike Medical Technology Co., Ltd.

決定日2026-05-28

製品コードNFO

諮問委員会Please provide the source text to translate.

決定大幅同等

医療機器の概要

Ulike Clear Zero (YC10 BU) is the device name listed in this FDA 510(k) record. The listed applicant is Guangxi Ulike Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-05-28 under 510(k) number K260895. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Ulike Clear Zero (YC10 BU)?

Ulike Clear Zero (YC10 BU) is a medical device that received FDA 510(k) clearance on 2026-05-28. The listed applicant is Guangxi Ulike Medical Technology Co., Ltd.. The 510(k) number is K260895.

When did Ulike Clear Zero (YC10 BU) receive FDA 510(k) clearance?

Ulike Clear Zero (YC10 BU) received FDA 510(k) clearance on 2026-05-28, under 510(k) number K260895.

Who is the listed applicant for Ulike Clear Zero (YC10 BU)?

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

What is the FDA product code for Ulike Clear Zero (YC10 BU)?

The FDA product code for Ulike Clear Zero (YC10 BU) is NFO.

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Ulikeクリアゼロ（YC10 BU）

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：NFO）

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