Cleared Traditional

K173332 - OMNI Surgical System (FDA 510(k) Clearance)

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

K173332 · Sight Sciences, Inc. · Ophthalmic device
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Dec 2017
Decision
59d
Days
Class 2
Risk

K173332 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 December 21, 2017 after a review of 59 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sight Sciences, Inc. devices

Submission Details

510(k) Number K173332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2017
Decision Date December 21, 2017
Days to Decision 59 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 110d · This submission: 59d
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 K173332.
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