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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
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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