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FDA 510(k)

Evolve System with the T3 Applicator

K-Number: K210877 · 2021-07-19

ApplicantInMode , Ltd.
Decision Date2021-07-19
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Evolve System with the T3 Applicator is a medical device manufactured by InMode , Ltd.. It received FDA 510(k) clearance on 2021-07-19 under approval number K210877. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Evolve System with the T3 Applicator?

Evolve System with the T3 Applicator is a medical device that received FDA 510(k) clearance on 2021-07-19. It is manufactured by InMode , Ltd.. The 510(k) number is K210877.

When was Evolve System with the T3 Applicator approved by the FDA?

Evolve System with the T3 Applicator received FDA 510(k) clearance on 2021-07-19, under approval number K210877.

What company makes Evolve System with the T3 Applicator?

Evolve System with the T3 Applicator is manufactured by InMode , Ltd..

What is the FDA product code for Evolve System with the T3 Applicator?

The FDA product code for Evolve System with the T3 Applicator is PBX.

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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 K201285InMode Evolve System with the Tone Applicator K221571InMode Multi-system

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Related Devices (Code: PBX)

K162512truSculptCutera, Inc. K161458Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep CareIndiba USA, Inc. K161551TR-100BTL Industries, Inc. K161043Profound SystemSyneron Candela Corporation K160329InMode System MiniFX HandpieceInmode MD , Ltd. K161199EndyMed Contour HandpieceEndymed Medical, Ltd.

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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