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FDA 510(k)

InMode Evolve System with the Tone Applicator

K-Number: K201285 · 2021-03-05

ApplicantInMode , Ltd.
Decision Date2021-03-05
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing InMode , Ltd. as applicant

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Related Devices (Code: IPF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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