K-number	K162851
Device name	eLyx-PRO
Applicant	Intelligent Sensory Concept SA
Product code	GEX
Device class	Class II
Decision date	Jan 24, 2017
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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eLyx-PRO

Everything you need for a 510(k) submission. Nothing you don't.