510(k) K083771

RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP by Clarity Medical Systems — Product Code HKI

K083771 is an FDA 510(k) premarket notification submitted by Clarity Medical Systems for the device "RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP". The FDA issued a decision of Substantially Equivalent on January 30, 2009. 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.