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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name biomicroscope, slit-lamp, ac-powered
510(k) Number K913852
Device Name LASER FLARE METER
Applicant
KOWA OPTIMED, INC.
20001 SOUTH VERMONT AVE.
TORRANCE,  CA  90502
Applicant Contact HIROSHI OKADA
Correspondent
KOWA OPTIMED, INC.
20001 SOUTH VERMONT AVE.
TORRANCE,  CA  90502
Correspondent Contact HIROSHI OKADA
Regulation Number886.1850
Classification Product Code
HJO  
Date Received08/27/1991
Decision Date 02/07/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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