FDA 510(k)

维纳斯速度二极管激光系统

K号: K162765 · 2017-01-11

决定日期2017-01-11

产品代码GEX

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决定实质等同

器械摘要

Venus Velocity Diode Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Venus Concept , Ltd.. It received FDA 510(k) clearance on 2017-01-11 under 510(k) number K162765. 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 Venus Velocity Diode Laser System?

Venus Velocity Diode Laser System is a medical device that received FDA 510(k) clearance on 2017-01-11. The listed applicant is Venus Concept , Ltd.. The 510(k) number is K162765.

When did Venus Velocity Diode Laser System receive FDA 510(k) clearance?

Venus Velocity Diode Laser System received FDA 510(k) clearance on 2017-01-11, under 510(k) number K162765.

Who is the listed applicant for Venus Velocity Diode Laser System?

The FDA 510(k) record lists Venus Concept , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Venus Velocity Diode Laser System?

The FDA product code for Venus Velocity Diode Laser System is GEX. This falls under the Gastroenterology category.

列明Venus Concept , Ltd.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。

K153717维纳斯·维萨系统 K152790维纳斯·维萨系统

官方来源

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