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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tonometer, Ac-Powered
510(k) Number K253039
Device Name AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA
Applicant
Topcon Corporation
75-1 Hasunuma-Cho
Itabashi-Ku
Tokyo,  JP 174-8580
Applicant Contact Tomoka Nishiyama
Correspondent
Orasi Consulting, LLC
226 1st St.
Bonita Springs,  FL  34134
Correspondent Contact Lena Sattler
Regulation Number886.1930
Classification Product Code
HKX  
Subsequent Product Code
MXK  
Date Received09/22/2025
Decision Date 11/07/2025
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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