510(k) K063343

BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM by Bioptigen, Inc. — Product Code HLI

K063343 is an FDA 510(k) premarket notification submitted by Bioptigen, Inc. for the device "BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on December 13, 2006. The device falls under product code HLI (Ophthalmoscope, Ac-Powered), a Class II device regulated under 21 CFR 886.1570. Bioptigen, Inc. has at least 3 other 510(k) clearances on record.