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FDA 510(k) Applications Submitted by Bioptigen, Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K120057
01/09/2012
ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)
BIOPTIGEN, INC.
K162783
10/03/2016
EnFocus 2300, EnFocus 4400
Bioptigen, Inc.
K063343
11/06/2006
BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM
BIOPTIGEN, INC.
K150722
03/20/2015
EnFocus 2300, EnFocus 4400
BIOPTIGEN, INC.
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