Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by InMode , Ltd.. It received FDA 510(k) clearance on 2021-03-05 under approval 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. It is manufactured by InMode , Ltd.. The 510(k) number is K201285.

When was InMode Evolve System with the Tone Applicator approved by the FDA?

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

What company makes InMode Evolve System with the Tone Applicator?

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

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.

Related Clinical Trials

NCT02759744 Fusion Guided Focal Laser Ablation of Prostate Cancer ENROLLING_BY_INVITATION NCT06634459 POMEGRANATE Trial: Comparing Reia Pessary Versus Standard of Care Pessary for Pelvic Organ Prolapse Treatment RECRUITING NCT04195568 Evaluation of Safety and Effectiveness of Stryker Surpass Evolve™ Flow Diverter System ACTIVE_NOT_RECRUITING

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 K221571InMode Multi-system

View all 15 devices →

Related Devices (Code: IPF)

K160614Xcite Clinical StationRestorative Therapies, Inc. K163067CyMedica e-vive™ System; CY-1000Cymedica Orthopedics, Inc. K160992HPM-6000BTL Industries, Inc. K151922StimSox(TM) SystemStimmed, LLC K153696Chattanooga Revolution WirelessDjo, LLC K160299geko(TM) Plus R-2 Neuromuscular StimulatorFirstkind Limited

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.

↑