OMNI Ultra Surgical System (1-110)— 510(k) K253760

Name: FDA 510(k) clearance K253760
Creator: U.S. Food and Drug Administration
Published: 2026-08-04

Substantially Equivalent

Sight Sciences, Inc.

FDA 510(k) clearance K253760 for OMNI Ultra Surgical System (1-110), Substantially Equivalent on 2026-08-04. Applicant: Sight Sciences, Inc.. Device class: 2.

Clearance details

Applicant: Sight Sciences, Inc.
Product code: Code MRH
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2025-11-25
Decision date: 2026-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, CA, US

Download summary PDF View on FDA.gov ↗

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