510(k) K954781

KOWA GENESIS HAND-HELD FUNDUS CAMERA by Kowa Optimed, Inc. — Product Code HKI

K954781 is an FDA 510(k) premarket notification submitted by Kowa Optimed, Inc. for the device "KOWA GENESIS HAND-HELD FUNDUS CAMERA". The FDA issued a decision of Substantially Equivalent on December 1, 1995. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Kowa Optimed, Inc. has at least 9 other 510(k) clearances on record.