LightWalker激光系统家族
K号: K193661 · 2020-03-25
广告
器械摘要
LightWalker Laser System Family is the device name listed in this FDA 510(k) record. The listed applicant is Fotona D.O.O.. It received FDA 510(k) clearance on 2020-03-25 under 510(k) number K193661. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常见问题
What is the LightWalker Laser System Family?
LightWalker Laser System Family is a medical device that received FDA 510(k) clearance on 2020-03-25. The listed applicant is Fotona D.O.O.. The 510(k) number is K193661.
When did LightWalker Laser System Family receive FDA 510(k) clearance?
LightWalker Laser System Family received FDA 510(k) clearance on 2020-03-25, under 510(k) number K193661.
Who is the listed applicant for LightWalker Laser System Family?
FDA 510(k)记录显示Fotona D.O.O.为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for LightWalker Laser System Family?
The FDA product code for LightWalker Laser System Family is GEX. This falls under the Gastroenterology category.
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。
列明Fotona D.O.O.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。
相关器械（代码：GEX）
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。
K254199PicoreMax（PicoreMax）BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI 系统Lumenis Be, Ltd.K261047牙科二极管激光设备（激光笔）Guilin Kevin Peter Technology Co., Ltd.K261817二极管激光治疗系统（PZ-BDT67-01，PZ-BDT67-02）Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED治疗设备（QLXY-01）Beijing Nubway S&T 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。
广告