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510(k) K220032

iStent infinite Trabecular Micro-Bypass System, Model iS3 by Glaukos Corporation — Product Code KYF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2022
Date Received
January 5, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Eye Valve
Device Class
Class II
Regulation Number
886.3920
Review Panel
OP
Submission Type

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