FDA 510(k)

方形脱毛器家族（Alex，Alex2，Nd:Yag，Alex+Nd:Yag）

K号: K161632 · 2016-12-08

决定日期2016-12-08

产品代码GEX

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决定实质等同

器械摘要

FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag) is the device name listed in this FDA 510(k) record. The listed applicant is Bios S.R.L.. It received FDA 510(k) clearance on 2016-12-08 under 510(k) number K161632. 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 FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)?

FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag) is a medical device that received FDA 510(k) clearance on 2016-12-08. The listed applicant is Bios S.R.L.. The 510(k) number is K161632.

When did FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag) receive FDA 510(k) clearance?

FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag) received FDA 510(k) clearance on 2016-12-08, under 510(k) number K161632.

Who is the listed applicant for FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)?

The FDA 510(k) record lists Bios S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)?

The FDA product code for FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag) is GEX. This falls under the Gastroenterology category.

列明Bios S.R.L.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。

K243445Splendor X（Alex，Alex2，Nd:YAG，Alex+Nd:YAG）K241407Splendor X（Alex，Alex2，Nd:YAG，Alex+Nd:YAG）K230755NuEra 紧密射频型号 OptiStream K223856NuEra 紧密射频系列 K223907NuEra 紧密射频型号 APMD145.M70-US K210867NuEra 紧密射频，NuEra 紧密射频加

查看所有 10 个设备 →

官方来源

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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。