InMode Evolve System with the Tone Applicator— 510(k) K201285

Name: FDA 510(k) clearance K201285
Creator: U.S. Food and Drug Administration
Published: 2021-03-05

Substantially Equivalent

InMode , Ltd.

FDA 510(k) clearance K201285 for InMode Evolve System with the Tone Applicator, Substantially Equivalent on 2021-03-05. Applicant: InMode , Ltd.. Device class: 2.

Clearance details

Applicant: InMode , Ltd.
Product code: Code IPF
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2020-05-13
Decision date: 2021-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam, IL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.