K-number	K193431
Device name	AlignRT Plus
Applicant	Vision Rt, Ltd.
Product code	IYE
Device class	Class II
Decision date	Jan 3, 2020
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.