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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 K262637
Device Name SLIT LAMP SL-D4 (Type: LED)
Applicant
Topcon Corporation
75-1 Hasunuma-Cho
Itabashi-Ku
Tokyo,  JP 174-8580
Applicant Contact Tomoka Nishiyama
Correspondent
O’Connell Regulatory Consultants, Inc.
44 Oak St.
Stoneham,  MA  02180
Correspondent Contact Maureen O’Connell
Regulation Number886.1850
Classification Product Code
HJO  
Date Received07/29/2026
Decision Date 09/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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