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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microscope, Specular
510(k) Number K142417
Device Name SP-1PSpecular Microscope
Applicant
Topcon Corporation
75-1 Hasunuma-Cho
Itabashi-Ku
Tokyo,  JP 174-8580
Applicant Contact Michael Gusel
Correspondent
Ora
300 Brickstone Sq.
Andover,  MA  01810
Correspondent Contact Ryan Bouchard
Regulation Number886.1850
Classification Product Code
NQE  
Date Received08/28/2014
Decision Date 05/29/2015
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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