FDA 510(k)

ID-500 iRestore生发系统

K号: K213094 · 2021-12-22

决定日期2021-12-22

产品代码OAP

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决定实质等同

器械摘要

ID-500 iRestore Hair Growth System is the device name listed in this FDA 510(k) record. The listed applicant is Freedom Laser Therapy, Inc.. It received FDA 510(k) clearance on 2021-12-22 under 510(k) number K213094. 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 ID-500 iRestore Hair Growth System?

ID-500 iRestore Hair Growth System is a medical device that received FDA 510(k) clearance on 2021-12-22. The listed applicant is Freedom Laser Therapy, Inc.. The 510(k) number is K213094.

When did ID-500 iRestore Hair Growth System receive FDA 510(k) clearance?

ID-500 iRestore Hair Growth System received FDA 510(k) clearance on 2021-12-22, under 510(k) number K213094.

Who is the listed applicant for ID-500 iRestore Hair Growth System?

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

What is the FDA product code for ID-500 iRestore Hair Growth System?

The FDA product code for ID-500 iRestore Hair Growth System is OAP.

列明Freedom Laser Therapy, 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。

K222081ID-510 iRestore精英版 K183417iRestore 专业版 282 K151662iRestore

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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