510(k) K081858

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

K081858 is an FDA 510(k) premarket notification submitted by Clarity Medical Systems for the device "RETCAM 3 OPHTHALMIC IMAGING SYSTEM". The FDA issued a decision of Substantially Equivalent on November 5, 2008. 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.