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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 K253176
Device Name TearView
Applicant
Beyond 700 Pty, Ltd.
Unit 38, 9 Hoyle Ave.
Castle Hill,  AU 2154
Applicant Contact Burkhardt Schuett
Correspondent
Beyond 700 Pty, Ltd.
8 Miller St.
Petersham,  AU 2049
Correspondent Contact Burkhardt Schuett
Regulation Number886.1120
Classification Product Code
HKI  
Date Received09/26/2025
Decision Date 06/22/2026
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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