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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 K253760
Device Name OMNI Ultra Surgical System (1-110)
Applicant
Sight Sciences, Inc.
4040 Campbell Ave. Suite 100
Menlo Park,  CA  94025
Applicant Contact Rachel Franco
Correspondent
Sight Sciences, Inc.
4040 Campbell Ave. Suite 100
Menlo Park,  CA  94025
Correspondent Contact Rachel Franco
Regulation Number880.5725
Classification Product Code
MRH  
Subsequent Product Code
HMZ  
Date Received11/25/2025
Decision Date 08/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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