510(k) K954780

KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C by Kowa Optimed, Inc. — Product Code HKI

K954780 is an FDA 510(k) premarket notification submitted by Kowa Optimed, Inc. for the device "KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C". 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.