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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Phacofragmentation
510(k) Number K250501
Device Name System Sophi
Applicant
This AG
Widnauerstrasse 1
Heerbrugg,  CH 9435
Applicant Contact Mr. Kai Kremnitzer
Correspondent
Regulatory Pathways Group, Inc.
440 N Barranca Ave. #2471
Covina,  CA  91723
Correspondent Contact Anne-Marie Ripley
Regulation Number886.4670
Classification Product Code
HQC  
Subsequent Product Code
HQE  
Date Received02/20/2025
Decision Date 11/14/2025
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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