K-number	K180189
Device name	InMode System with Fractora3D/3D-90 Applicators
Applicant	Inmode MD , Ltd.
Product code	GEI
Device class	Class II
Decision date	Jun 1, 2018
Decision	Substantially Equivalent
Regulation	878.4400

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View the full FDA submission: accessdata.fda.gov

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InMode System with Fractora3D/3D-90 Applicators

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