FDA 510(k)

优立克清零（YC10 BU）

K号: K260895 · 2026-05-28

申请人Guangxi Ulike Medical Technology Co., Ltd.

决定日期2026-05-28

产品代码NFO

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决定实质等同

器械摘要

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.

常见问题

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.

官方来源

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优立克清零（YC10 BU）

器械摘要

常见问题

相关临床试验

相关器械（代码：NFO）

官方来源