FDA 510(k)

InMode系统与Morpheus8应用器

K号: K231790 · 2023-07-20

决定日期2023-07-20

产品代码GEI

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决定实质等同

器械摘要

The InMode System with the Morpheus8 Applicators is the device name listed in this FDA 510(k) record. The listed applicant is InMode , Ltd.. It received FDA 510(k) clearance on 2023-07-20 under 510(k) number K231790. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the The InMode System with the Morpheus8 Applicators?

The InMode System with the Morpheus8 Applicators is a medical device that received FDA 510(k) clearance on 2023-07-20. The listed applicant is InMode , Ltd.. The 510(k) number is K231790.

When did The InMode System with the Morpheus8 Applicators receive FDA 510(k) clearance?

The InMode System with the Morpheus8 Applicators received FDA 510(k) clearance on 2023-07-20, under 510(k) number K231790.

Who is the listed applicant for The InMode System with the Morpheus8 Applicators?

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

What is the FDA product code for The InMode System with the Morpheus8 Applicators?

The FDA product code for The InMode System with the Morpheus8 Applicators is GEI.

列明InMode , 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。

K251254Ignite RF System K251632Optimas MAX系统 K242598DEFINE 系统 (AG612444A)K240780InMode射频系统 K240017InMode系统带Morpheus8 90探头 K233642InMode射频系统

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相关器械（代码：GEI）

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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