Cleared Traditional

K253760 - OMNI Ultra Surgical System (1-110)

K253760 is an FDA 510(k) clearance for OMNI Ultra Surgical System (1-110), manufactured by Sight Sciences, Inc.. The device is a Class 2 Ophthalmic device with product code MRH cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K253760 · Sight Sciences, Inc. · Ophthalmic device
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Aug 2026
Decision
252d
Days
Class 2
Risk

K253760 is an FDA 510(k) clearance for the OMNI Ultra Surgical System (1-110). Classified as Pump, Infusion, Ophthalmic (product code MRH), Class II - Special Controls.

Submitted by Sight Sciences, Inc. (Menlo Park, US). The FDA issued a Cleared decision on August 4, 2026 after a review of 252 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 880.5725 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Sight Sciences, Inc. devices

FDA 510(k) Submission Details - K253760

510(k) Number K253760 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2025
Decision Date August 04, 2026
Days to Decision 252 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 110d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRH Device Classification - Class 2, Special Controls

Product Code MRH Pump, Infusion, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - MRH Pump, Infusion, Ophthalmic

All 18
Devices cleared under the same product code (MRH) and FDA review panel - the closest regulatory comparables to K253760.
VIA360™ Surgical System
K243503 · New World Medical, Inc. · Feb 2025
OMNI Surgical System
K232214 · Sight Sciences, Inc. · Aug 2023
TrabEx Pro
K213173 · Microsurgical Technologies, Inc. · Jun 2022
iPrime Viscodelivery System
K212797 · Glaukos · Jan 2022
Streamline Surgical System
K211680 · New World Medical, Inc. · Oct 2021
OMNI Surgical System
K202678 · Sight Sciences, Inc. · Mar 2021