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OMNI Surgical System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K232214

by Sight Sciences, Inc.

Identifiers

510(k) Number
K232214 FDA 510(k)
FDA Product Code
MRH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5725 FDA 510(k)
Regulation Number
880.5725 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The OMNI Surgical System is a Pump, Infusion, Ophthalmic device designed for canaloplasty—specifically, microcatheterization and transluminal viscodilation of Schlemm’s canal—followed by trabeculotomy (partial incision of the trabecular meshwork). It is intended for reducing intraocular pressure in adult patients with primary open-angle glaucoma (POAG) through minimally invasive, implant-free procedures.

This system is supplied as a reusable medical device and is classified under Device Class II per FDA regulations. It is authorized for use in general hospital settings, with FDA 510(k) clearance and MDR compliance. The device is not MRI-safe, and its ergonomic design is optimized for surgical precision. Storage and handling must adhere to sterile medical device protocols as specified in the manufacturer’s instructions.

Frequently asked questions

What is the OMNI Surgical System primarily used for in clinical practice?

The OMNI Surgical System is designed for canaloplasty, a minimally invasive procedure to reduce intraocular pressure in adult patients with primary open-angle glaucoma (POAG). It performs microcatheterization and transluminal viscodilation of Schlemm’s canal, followed by trabeculotomy (a partial incision of the trabecular meshwork), without requiring an implant.

Is the OMNI Surgical System reusable or single-use, and what does this mean for my practice?

The OMNI Surgical System is supplied as a reusable medical device, meaning it is intended for multiple uses after proper cleaning, disinfection, and sterilization between procedures. This requires adherence to strict sterile medical device protocols as outlined in the manufacturer’s instructions to ensure safety and efficacy.

Are there any special storage or handling requirements for the OMNI Surgical System?

Yes, the OMNI Surgical System must be stored and handled according to sterile medical device protocols specified by the manufacturer. Since it is reusable, proper cleaning, disinfection, and sterilization between uses are critical to maintain its performance and prevent contamination.

Can the OMNI Surgical System be used in any MRI environment, and why?

No, the OMNI Surgical System is explicitly not MRI-safe. This means it should not be used or stored in an MRI environment, as exposure to magnetic fields could compromise the device’s integrity or pose risks to patients.

What regulatory pathways does the OMNI Surgical System follow, and where is it authorized for use?

The OMNI Surgical System holds FDA 510(k) clearance and complies with the EU Medical Device Regulation (MDR). It is classified as a Device Class II under FDA regulations and is authorized for use in general hospital settings, as indicated by its advisory committee designation (General Hospital).

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Experience the Ergo-Series of the OMNI® Surgical System, Sight Sciences Launches the Ergo-Series of the OMNI® Surgical System, Experience the Ergo-Series of the OMNI® Surgical System

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sight Sciences, Inc.

Sources (2)

  • FDA 510(k) K232214 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 11, 2026