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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Ophthalmic
510(k) Number K173332
Device Name OMNI Surgical System
Applicant
Sight Sciences, Inc.
3000 Sand Hill Road
Building 3, Suite 105
Menlo Park,  CA  94025
Applicant Contact Anne-Marie Ripley
Correspondent
Sight Sciences, Inc.
3000 Sand Hill Road
Building 3, Suite 105
Menlo Park,  CA  94025
Correspondent Contact Anne-Marie Ripley
Regulation Number880.5725
Classification Product Code
MRH  
Subsequent Product Code
HMZ  
Date Received10/23/2017
Decision Date 12/21/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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