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FDA 510(k)

InMode System with Tone Applicator

K-Number: K192249 · 2019-12-17

ApplicantInMode , Ltd.
Decision Date2019-12-17
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

InMode System with Tone Applicator is a medical device manufactured by InMode , Ltd.. It received FDA 510(k) clearance on 2019-12-17 under approval number K192249. 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 System with Tone Applicator?

InMode System with Tone Applicator is a medical device that received FDA 510(k) clearance on 2019-12-17. It is manufactured by InMode , Ltd.. The 510(k) number is K192249.

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

InMode System with Tone Applicator received FDA 510(k) clearance on 2019-12-17, under approval number K192249.

What company makes InMode System with Tone Applicator?

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

What is the FDA product code for InMode System with Tone Applicator?

The FDA product code for InMode System with Tone Applicator is IPF.

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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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