FDA 510(k)

InMode Evolve 系统带 Tone 应用程序

K号: K201285 · 2021-03-05

决定日期2021-03-05

产品代码IPF

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决定实质等同

器械摘要

InMode Evolve System with the Tone 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 2021-03-05 under 510(k) number K201285. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the InMode Evolve System with the Tone Applicator?

InMode Evolve System with the Tone Applicator is a medical device that received FDA 510(k) clearance on 2021-03-05. The listed applicant is InMode , Ltd.. The 510(k) number is K201285.

When did InMode Evolve System with the Tone Applicator receive FDA 510(k) clearance?

InMode Evolve System with the Tone Applicator received FDA 510(k) clearance on 2021-03-05, under 510(k) number K201285.

Who is the listed applicant for InMode Evolve System with the Tone 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 InMode Evolve System with the Tone Applicator?

The FDA product code for InMode Evolve System with the Tone Applicator is IPF.

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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官方来源

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