FDA 510(k)

Evolve系统带Transform应用器

K号: K231495 · 2023-10-13

决定日期2023-10-13

产品代码GEI

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决定实质等同

器械摘要

The Evolve System with the Transform Applicator is the device name listed in this FDA 510(k) record. The listed applicant is InMode , Ltd.. It received FDA 510(k) clearance on 2023-10-13 under 510(k) number K231495. 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 Evolve System with the Transform Applicator?

The Evolve System with the Transform Applicator is a medical device that received FDA 510(k) clearance on 2023-10-13. The listed applicant is InMode , Ltd.. The 510(k) number is K231495.

When did The Evolve System with the Transform Applicator receive FDA 510(k) clearance?

The Evolve System with the Transform Applicator received FDA 510(k) clearance on 2023-10-13, under 510(k) number K231495.

Who is the listed applicant for The Evolve System with the Transform Applicator?

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 Evolve System with the Transform Applicator?

The FDA product code for The Evolve System with the Transform Applicator 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。

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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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