OMNI Ultra Surgical System (1-110)— 510(k) K253760
Substantially EquivalentSight 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.
Summary
Sight Sciences' OMNI Ultra Surgical System, listed as 1-110, is filed under product code MRH, ophthalmic infusion pumps. The record doesn't describe the system further.
Class II, 21 CFR 880.5725. The Ophthalmic review panel handled it as a Traditional 510(k), though the record lists General Hospital as the classification panel.
Sight Sciences filed from Menlo Park, California. The decision came 252 calendar days after FDA received it (November 25, 2025 to August 4, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Sight Sciences, Inc.
- Product code
- Product code MRH
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Menlo Park, CA, US
Recent devices under product code MRH
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