Cleared Traditional

K202678 - OMNI Surgical System (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202678 · Sight Sciences, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2021
Decision
167d
Days
Class 2
Risk

K202678 is an FDA 510(k) clearance for the OMNI Surgical System. 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 March 1, 2021 after a review of 167 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

Submission Details

510(k) Number K202678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2020
Decision Date March 01, 2021
Days to Decision 167 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
57d slower than avg
Panel avg: 110d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K202678.
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