K-number	K120057
Device name	ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)
Applicant	Bioptigen, Inc.
Product code	HLI
Device class	Class II
Decision date	May 11, 2012
Decision	Substantially Equivalent
Regulation	886.1570

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View the full FDA submission: accessdata.fda.gov

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ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)

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