K-number	K181537
Device name	GLOW800
Applicant	Leica Microsystems (Schweiz) AG
Product code	IZI
Device class	Class II
Decision date	Sep 7, 2018
Decision	Substantially Equivalent
Regulation	892.1600

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Source

View the full FDA submission: accessdata.fda.gov

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GLOW800

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