510(k) K913852

LASER FLARE METER by Kowa Optimed, Inc. — Product Code HJO

K913852 is an FDA 510(k) premarket notification submitted by Kowa Optimed, Inc. for the device "LASER FLARE METER". The FDA issued a decision of Substantially Equivalent on February 7, 1992. 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.