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FDA 510(k)

The Evolve System with the Transform Applicator

K-Number: K231495 · 2023-10-13

ApplicantInMode , Ltd.
Decision Date2023-10-13
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

The Evolve System with the Transform Applicator is a medical device manufactured by InMode , Ltd.. It received FDA 510(k) clearance on 2023-10-13 under approval number K231495. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by InMode , Ltd.. The 510(k) number is K231495.

When was The Evolve System with the Transform Applicator approved by the FDA?

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

What company makes The Evolve System with the Transform Applicator?

The Evolve System with the Transform Applicator is manufactured by InMode , Ltd..

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.

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Related PubMed Literature

PMID: 41608759 Collaborative and Cooperative Hospital "In-House" Medical Device Development and Implementation in the AI Age: The European Responsible AI Development (EURAID) Framework Compatible With European Values. Journal of medical Internet research (2026) PMID: 40127785 Clinical Implementation of Artificial Intelligence in Gastroenterology: Current Landscape, Regulatory Challenges, and Ethical Issues. Gastroenterology (2025) PMID: 39925011 Is more data always better? On alternative policies to mitigate bias in Artificial Intelligence health systems. Bioethics (2025)

Other Devices by InMode , Ltd.

K192249InMode System with Tone Applicator K201150InMode RF Multi-System K200947InMode System with the Morhpeus8 Applicators K200293InMode System with vTone Applicator K210877Evolve System with the T3 Applicator K201285InMode Evolve System with the Tone Applicator

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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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