510(k) K862379

CORNEAL MODELING SYSTEM by Computed Anatomy, Inc. — Product Code HJO

K862379 is an FDA 510(k) premarket notification submitted by Computed Anatomy, Inc. for the device "CORNEAL MODELING SYSTEM". The FDA issued a decision of Substantially Equivalent on August 25, 1986. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Computed Anatomy, Inc. has at least 3 other 510(k) clearances on record.