FDA 510(k)

CurrentBody Skin 双光头发生长头盔（型号：MZ-07A）

K号: K251017 · 2025-06-17

申请人Shenzhen Kaiyan Medical Equipment Co., Ltd.

决定日期2025-06-17

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

CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-06-17 under 510(k) number K251017. 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 CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)?

CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) is a medical device that received FDA 510(k) clearance on 2025-06-17. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K251017.

When did CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) receive FDA 510(k) clearance?

CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) received FDA 510(k) clearance on 2025-06-17, under 510(k) number K251017.

Who is the listed applicant for CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)?

FDA 510(k)记录将深圳凯研医疗设备有限公司列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)?

The FDA product code for CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) is OAP.

列明Shenzhen Kaiyan Medical Equipment Co., Ltd.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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查看所有 24 个设备 →

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。

K262183头发生长头盔（TK-176，TK-600，TK-500，TK-282，TK-500A，TK-282A，TK-126，TK-60）Shenzhen Nuon Medical Equipment Co., Ltd.K262254毛发生长梳（X-GC01）Guangdong Ashmore Health Technology Co., Ltd.K261675CHZL红光疗法生发帽（型号：CHZL-120BK-L52D，CHZL-120BK-L53D，CHZL-120BK-L54D）Shenzhen Chuanghong Zhilian Technology Co., Ltd.K261253激光生发设备（HR-H1，HR-H2，HR-H3，HR-H4，HR-H5，HR-H6，HR-H7，HR-H8，HR-H9，HR-H10，HR-I1，HR-I2，HR-I3，HR-I4，HR-I5）Ziree Co., Ltd.K253231激光生发系统（激光帽128，激光头盔272，激光头盔352，激光头盔552，激光头盔500）Hubei Yjt Technology Co.,Ltd K260899激光生发设备（F21151，F21152，F21153，F21154，F21155，F21156，F21157，F21158，F21159）Zdeer Technology (Henan) Co., Ltd.

官方来源

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