FDA 510(k)

激光帽系列激光器300，224，120 & 80

K号: K203826 · 2021-03-29

决定日期2021-03-29

产品代码OAP

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决定实质等同

器械摘要

LaserCap Family of Lasers 300, 224, 120 & 80 is the device name listed in this FDA 510(k) record. The listed applicant is Transdermal Cap, Inc.. It received FDA 510(k) clearance on 2021-03-29 under 510(k) number K203826. 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 LaserCap Family of Lasers 300, 224, 120 & 80?

LaserCap Family of Lasers 300, 224, 120 & 80 is a medical device that received FDA 510(k) clearance on 2021-03-29. The listed applicant is Transdermal Cap, Inc.. The 510(k) number is K203826.

When did LaserCap Family of Lasers 300, 224, 120 & 80 receive FDA 510(k) clearance?

LaserCap Family of Lasers 300, 224, 120 & 80 received FDA 510(k) clearance on 2021-03-29, under 510(k) number K203826.

Who is the listed applicant for LaserCap Family of Lasers 300, 224, 120 & 80?

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

What is the FDA product code for LaserCap Family of Lasers 300, 224, 120 & 80?

The FDA product code for LaserCap Family of Lasers 300, 224, 120 & 80 is OAP.

列明Transdermal Cap, 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。

K161875LaserCap300，LaserCap224，LaserCap120，LaserCap80

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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