510(k) K013805

KOWA AUTOMATED TONOMETER KT-500 by Kowa Optimed, Inc. — Product Code HKX

K013805 is an FDA 510(k) premarket notification submitted by Kowa Optimed, Inc. for the device "KOWA AUTOMATED TONOMETER KT-500". The FDA issued a decision of Substantially Equivalent on October 11, 2002. The device falls under product code HKX (Tonometer, Ac-Powered), a Class II device regulated under 21 CFR 886.1930. Kowa Optimed, Inc. has at least 9 other 510(k) clearances on record.