510(k) K801659

BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE by Coburn Optical Ind., Inc. — Product Code HJO

K801659 is an FDA 510(k) premarket notification submitted by Coburn Optical Ind., Inc. for the device "BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE". The FDA issued a decision of Substantially Equivalent on September 9, 1980. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Coburn Optical Ind., Inc. has at least 10 other 510(k) clearances on record.