K-number	K162039
Device name	OptosAdvance 4.0 Software
Applicant	Optos Plc.
Product code	NFJ
Device class	Class II
Decision date	Feb 8, 2017
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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OptosAdvance 4.0 Software

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