K-number	K140120
Device name	EPIC 10
Applicant	Biolase, Inc.
Product code	GEX
Device class	Class II
Decision date	Oct 10, 2014
Decision	Substantially Equivalent
Regulation	878.4810

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Source

View the full FDA submission: accessdata.fda.gov

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EPIC 10

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