FDA 510(k)

激光帽，型号：Hat-01

K号: K232356 · 2023-10-24

决定日期2023-10-24

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

Laser Cap, Model: Hat-01 is the device name listed in this FDA 510(k) record. The listed applicant is Hubei Yjt Technology Co.,Ltd. It received FDA 510(k) clearance on 2023-10-24 under 510(k) number K232356. 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 Laser Cap, Model: Hat-01?

Laser Cap, Model: Hat-01 is a medical device that received FDA 510(k) clearance on 2023-10-24. The listed applicant is Hubei Yjt Technology Co.,Ltd. The 510(k) number is K232356.

When did Laser Cap, Model: Hat-01 receive FDA 510(k) clearance?

Laser Cap, Model: Hat-01 received FDA 510(k) clearance on 2023-10-24, under 510(k) number K232356.

Who is the listed applicant for Laser Cap, Model: Hat-01?

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

What is the FDA product code for Laser Cap, Model: Hat-01?

The FDA product code for Laser Cap, Model: Hat-01 is OAP.

列明Hubei Yjt Technology 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。

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）K230134激光治疗生发梳，型号：Lasercomb-001 & Lasercomb-002

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.

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