K-number	K123371
Device name	ALIGNRT PLUS
Applicant	Vision RT Limited
Product code	IYE
Device class	Class II
Decision date	Jan 8, 2013
Decision	Substantially Equivalent
Regulation	892.5050

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Source

View the full FDA submission: accessdata.fda.gov

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ALIGNRT PLUS

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