Cleared Special

K201953 - OMNI PLUS Surgical System (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K201953 · Sight Sciences, Inc. · Ophthalmic device
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Aug 2020
Decision
28d
Days
Class 2
Risk

K201953 is an FDA 510(k) clearance for the OMNI PLUS 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 August 11, 2020 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sight Sciences, Inc. devices

Submission Details

510(k) Number K201953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2020
Decision Date August 11, 2020
Days to Decision 28 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 110d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K201953.
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