FDA 510(k)

InMode System with Fractora3D/3D-90 Applicators

K-Number: K180189 · 2018-06-01

Decision Date2018-06-01

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

InMode System with Fractora3D/3D-90 Applicators is a medical device manufactured by Inmode MD , Ltd.. It received FDA 510(k) clearance on 2018-06-01 under approval number K180189. 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 InMode System with Fractora3D/3D-90 Applicators?

InMode System with Fractora3D/3D-90 Applicators is a medical device that received FDA 510(k) clearance on 2018-06-01. It is manufactured by Inmode MD , Ltd.. The 510(k) number is K180189.

When was InMode System with Fractora3D/3D-90 Applicators approved by the FDA?

InMode System with Fractora3D/3D-90 Applicators received FDA 510(k) clearance on 2018-06-01, under approval number K180189.

What company makes InMode System with Fractora3D/3D-90 Applicators?

InMode System with Fractora3D/3D-90 Applicators is manufactured by Inmode MD , Ltd..

What is the FDA product code for InMode System with Fractora3D/3D-90 Applicators?

The FDA product code for InMode System with Fractora3D/3D-90 Applicators is GEI.

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Official Source

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