510(k) K880920

LASER FLARE CELL METER FC-1000 by Kowa Optimed, Inc. — Product Code HJO

K880920 is an FDA 510(k) premarket notification submitted by Kowa Optimed, Inc. for the device "LASER FLARE CELL METER FC-1000". The FDA issued a decision of Substantially Equivalent on September 27, 1988. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Kowa Optimed, Inc. has at least 9 other 510(k) clearances on record.