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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Eye Valve
510(k) Number K220032
Device Name iStent infinite Trabecular Micro-Bypass System, Model iS3
Applicant
Glaukos Corporation
229 Avenida Fabricante
San Clemente,  CA  92672
Applicant Contact David S. Fernquist
Correspondent
Glaukos Corporation
229 Avenida Fabricante
San Clemente,  CA  92672
Correspondent Contact David S. Fernquist
Regulation Number886.3920
Classification Product Code
KYF  
Date Received01/05/2022
Decision Date 08/02/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT03639870
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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