510(k) K102859

RETCAM 3 OPTHALMIC IMAGING SYSTEM by Clarity Medical Systems — Product Code HKI

K102859 is an FDA 510(k) premarket notification submitted by Clarity Medical Systems for the device "RETCAM 3 OPTHALMIC IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on April 20, 2011. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Clarity Medical Systems has at least 3 other 510(k) clearances on record.