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FDA 510(k)

LLLT激光生发帽，型号：Hair Care 88，Hair Care 135，Hair Care 210。

K号: K213447 · 2022-01-19

申请人Shenzhen Cosbeauty Technology Co., Ltd.
决定日期2022-01-19
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

LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210. is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Cosbeauty Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-01-19 under 510(k) number K213447. 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 LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.?

LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210. is a medical device that received FDA 510(k) clearance on 2022-01-19. The listed applicant is Shenzhen Cosbeauty Technology Co., Ltd.. The 510(k) number is K213447.

When did LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210. receive FDA 510(k) clearance?

LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210. received FDA 510(k) clearance on 2022-01-19, under 510(k) number K213447.

Who is the listed applicant for LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.?

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

What is the FDA product code for LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.?

The FDA product code for LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210. is OAP.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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.,LtdK260899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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