FDA 510(k)

InMode Diolaze XL

K号: K170738 · 2017-08-07

决定日期2017-08-07

产品代码GEX

咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。

决定实质等同

器械摘要

InMode Diolaze XL is the device name listed in this FDA 510(k) record. The listed applicant is Inmode MD , Ltd.. It received FDA 510(k) clearance on 2017-08-07 under 510(k) number K170738. 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 InMode Diolaze XL?

InMode Diolaze XL is a medical device that received FDA 510(k) clearance on 2017-08-07. The listed applicant is Inmode MD , Ltd.. The 510(k) number is K170738.

When did InMode Diolaze XL receive FDA 510(k) clearance?

InMode Diolaze XL received FDA 510(k) clearance on 2017-08-07, under 510(k) number K170738.

Who is the listed applicant for InMode Diolaze XL?

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

What is the FDA product code for InMode Diolaze XL?

The FDA product code for InMode Diolaze XL is GEX. This falls under the Gastroenterology category.

列明Inmode MD , 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。

K210492InMode射频Pro系统 K192695InMode系统带Morpheus8 (Fractora)探头 K191855EmFace Device K183450EmBody System K182325InMode射频系统 K180719InMode Diolaze 系统

查看所有 16 个设备 →

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。