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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tomography, Optical Coherence
510(k) Number K233561
Device Name 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))
Applicant
Topcon Corporation
75-1 Hasunuma-Cho
Itabashi-Ku
Tokyo,  JP 174-8580
Applicant Contact Ryota Kitawaki
Correspondent
Orasi Consulting
226 1st St.
Bonita Springs,  FL  34134
Correspondent Contact Lena Sattler
Regulation Number886.1570
Classification Product Code
OBO  
Subsequent Product Code
HKI  
Date Received11/06/2023
Decision Date 04/10/2024
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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