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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 K233398
Device Name Faros Surgical System
Applicant
Oertli Instrumente AG
Hafnerwiesenstrasse 4
Berneck,  CH 9442
Applicant Contact Marianne Kesseli
Correspondent
CardioMed Device Consultants, LLC
1783 Forest Dr.
Suite 254
Annapolis,  MD  21401
Correspondent Contact Meagan Fagan
Regulation Number886.4670
Classification Product Code
HQC  
Subsequent Product Codes
GEI   HQE  
Date Received10/03/2023
Decision Date 06/27/2024
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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