
Kowa Optimed, Inc.
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KOWA AUTOMATED TONOMETER KT-500 is an FDA 510(k)-cleared medical device (K013805) manufactured by Kowa Optimed, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 10, 2002. Regulation: 8.