FDA 510(k)

Grivamax 头发增长系统

K号: K171895 · 2017-08-22

决定日期2017-08-22

产品代码OAP

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决定实质等同

器械摘要

Grivamax Hair Growth System is the device name listed in this FDA 510(k) record. The listed applicant is Leana Orders, Inc.. It received FDA 510(k) clearance on 2017-08-22 under 510(k) number K171895. 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 Grivamax Hair Growth System?

Grivamax Hair Growth System is a medical device that received FDA 510(k) clearance on 2017-08-22. The listed applicant is Leana Orders, Inc.. The 510(k) number is K171895.

When did Grivamax Hair Growth System receive FDA 510(k) clearance?

Grivamax Hair Growth System received FDA 510(k) clearance on 2017-08-22, under 510(k) number K171895.

Who is the listed applicant for Grivamax Hair Growth System?

The FDA 510(k) record lists Leana Orders, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Grivamax Hair Growth System?

The FDA product code for Grivamax Hair Growth System is OAP.

列明Leana Orders, Inc.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。

K211192Grivamax 激光系列，型号 272 和 148

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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