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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Ac-Powered
510(k) Number K221111
Device Name Non-Mydriatic Retinal Camera NW500
Applicant
Topcon Corporation
75-1 Hasunuma-Cho
Itabashi-Ku,  JP 174-8580
Applicant Contact Ryota Kitawaki
Correspondent
Oconnell Regulatory Consultants, Inc.
44 Oak St.
Stoneham,  MA  02180
Correspondent Contact Maureen OConnell
Regulation Number886.1120
Classification Product Code
HKI  
Date Received04/15/2022
Decision Date 08/29/2022
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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