FDA 510(k)

二极管激光脱毛设备

K号: K180353 · 2018-04-17

申请人Zhengzhou PZ Laser Slim Technology Co., Ltd.

决定日期2018-04-17

产品代码GEX

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决定实质等同

器械摘要

Diode laser hair removal device is the device name listed in this FDA 510(k) record. The listed applicant is Zhengzhou PZ Laser Slim Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-04-17 under 510(k) number K180353. 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 Diode laser hair removal device?

Diode laser hair removal device is a medical device that received FDA 510(k) clearance on 2018-04-17. The listed applicant is Zhengzhou PZ Laser Slim Technology Co., Ltd.. The 510(k) number is K180353.

When did Diode laser hair removal device receive FDA 510(k) clearance?

Diode laser hair removal device received FDA 510(k) clearance on 2018-04-17, under 510(k) number K180353.

Who is the listed applicant for Diode laser hair removal device?

FDA 510(k)记录将郑州普泽激光瘦身科技有限公司列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Diode laser hair removal device?

The FDA product code for Diode laser hair removal device is GEX. This falls under the Gastroenterology category.

列明Zhengzhou PZ Laser Slim Technology Co., 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。

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官方来源

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