510(k) K063378

CIRRUS HD-OCT, MODEL 4000 by Carl Zeiss Meditec, Inc. — Product Code HLI

K063378 is an FDA 510(k) premarket notification submitted by Carl Zeiss Meditec, Inc. for the device "CIRRUS HD-OCT, MODEL 4000". The FDA issued a decision of Substantially Equivalent on January 26, 2007. The device falls under product code HLI (Ophthalmoscope, Ac-Powered), a Class II device regulated under 21 CFR 886.1570. Carl Zeiss Meditec, Inc. has at least 10 other 510(k) clearances on record.