FDA 510(k)

iRestore

K号: K151662 · 2016-01-06

决定日期2016-01-06

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

iRestore 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 2016-01-06 under 510(k) number K151662. 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 iRestore?

iRestore is a medical device that received FDA 510(k) clearance on 2016-01-06. The listed applicant is Freedom Laser Therapy, Inc.. The 510(k) number is K151662.

When did iRestore receive FDA 510(k) clearance?

iRestore received FDA 510(k) clearance on 2016-01-06, under 510(k) number K151662.

Who is the listed applicant for iRestore?

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 iRestore?

The FDA product code for iRestore 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 K213094ID-500 iRestore生发系统 K183417iRestore 专业版 282

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

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。