510(k) clearances

OMNI Ultra Surgical System (1-110)

Sight Sciences, Inc. · General Hospital

K253760Substantially EquivalentTraditionalMRH
Open FDA's page for this record
Third party flag
N
City
Menlo Park
Advisory committee description
General Hospital
Address 1
4040 Campbell Ave. Suite 100
Statement or summary
Summary
Product code
MRH
Zip code
94025
Applicant
Sight Sciences, Inc.
Decision date
2026-08-04
Decision code
SESE
Country code
US
Device name
OMNI Ultra Surgical System (1-110)
Advisory committee
HO
Contact
Rachel Franco
K number
K253760
State
CA
Date received
2025-11-25
Review advisory committee
OP
Postal code
94025
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Pump, Infusion, Ophthalmic
Medical specialty description
General Hospital
Regulation number
880.5725
Device class
2
Registration number
2029275, 3010363671, 3009746061, 3019924, 1920664, 1450662, 1932402, 3004748528, 2246552, 3042158861, 1000125279, 1313525, 2183477, 3017616393, 2953359, 3007113251, 2183744, 3005641545
FEI number
3010363671, 3009746061, 1000119053, 1000306431, 3019924, 1920664, 1450662, 3004748528, 2246552, 3042158861, 2183477, 3017616393, 3007113251, 1000125279, 1317628, 2183744, 3000215205, 3005641545
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.