Bioptigen, Inc. - FDA 510(k) Cleared Devices
Recent clearances: EnFocus 2300, EnFocus 4400, EnFocus 2300, EnFocus 4400, ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Bioptigen, Inc. Ophthalmic ✕
4 devices
Cleared
Dec 09, 2016
EnFocus 2300, EnFocus 4400
Ophthalmic
67d
Cleared
Dec 02, 2015
EnFocus 2300, EnFocus 4400
Ophthalmic
257d
Cleared
May 11, 2012
ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)
Ophthalmic
123d
Cleared
Dec 13, 2006
BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM
Ophthalmic
37d