FDA 510(k)

InMode FRF Applicator

K-Number: K151273 · 2016-01-04

Decision Date2016-01-04

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

InMode FRF Applicator is a medical device manufactured by Inmode MD , Ltd.. It received FDA 510(k) clearance on 2016-01-04 under approval number K151273. 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 FRF Applicator?

InMode FRF Applicator is a medical device that received FDA 510(k) clearance on 2016-01-04. It is manufactured by Inmode MD , Ltd.. The 510(k) number is K151273.

When was InMode FRF Applicator approved by the FDA?

InMode FRF Applicator received FDA 510(k) clearance on 2016-01-04, under approval number K151273.

What company makes InMode FRF Applicator?

InMode FRF Applicator is manufactured by Inmode MD , Ltd..

What is the FDA product code for InMode FRF Applicator?

The FDA product code for InMode FRF Applicator is GEI.

Other Devices by Inmode MD , Ltd.

K163190InMode RF System K160329InMode System MiniFX Handpiece K153568InMode Plus System K151793InMode RF System K172302InMode PLUS System K171593InMode RF System

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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.