510(k) K090326

RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS by Clarity Medical Systems — Product Code HKI

K090326 is an FDA 510(k) premarket notification submitted by Clarity Medical Systems for the device "RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS". The FDA issued a decision of Substantially Equivalent on November 25, 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.