FDA 510(k)

Hair Regrowth Cap (Model: T-119-HRC)

K号: K253349 · 2025-12-24

决定日期2025-12-24

产品代码OAP

咨询委员会PM 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

Hair Regrowth Cap (Model: T-119-HRC) is the device name listed in this FDA 510(k) record. The listed applicant is Light Tree Ventures Europe B.V.. It received FDA 510(k) clearance on 2025-12-24 under 510(k) number K253349. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Hair Regrowth Cap (Model: T-119-HRC)?

Hair Regrowth Cap (Model: T-119-HRC) is a medical device that received FDA 510(k) clearance on 2025-12-24. The listed applicant is Light Tree Ventures Europe B.V.. The 510(k) number is K253349.

When did Hair Regrowth Cap (Model: T-119-HRC) receive FDA 510(k) clearance?

Hair Regrowth Cap (Model: T-119-HRC) received FDA 510(k) clearance on 2025-12-24, under 510(k) number K253349.

Who is the listed applicant for Hair Regrowth Cap (Model: T-119-HRC)?

The FDA 510(k) record lists Light Tree Ventures Europe B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hair Regrowth Cap (Model: T-119-HRC)?

The FDA product code for Hair Regrowth Cap (Model: T-119-HRC) is OAP.

列明Light Tree Ventures Europe B.V.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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相关器械（代码：OAP）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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