Identifiers
- 510(k) Number
- K173332 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 an ophthalmic pump and infusion device designed for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm’s canal) and trabeculotomy (trabecular meshwork incision) to manage intraocular pressure in adult patients with primary open-angle glaucoma. Classified as a Class II medical device, it is intended for use in general hospital settings and is substantially equivalent to existing predicate devices under FDA regulations.
This system is supplied as a reusable surgical instrument and is not sterile at time of shipment. It is intended for single-use per procedure and must be disposed of after use. The device is not MRI-safe and requires proper storage in a clean, dry environment as specified by the manufacturer. Authorized under FDA 510(k) clearance (K173332), it adheres to regulatory standards outlined in 21 CFR 880.5725.
Frequently asked questions
What is the OMNI Surgical System primarily used for in clinical practice?
The OMNI Surgical System is designed for canaloplasty (microcatheterization and dilation of Schlemm’s canal) and trabeculotomy (incision of the trabecular meshwork) to help manage intraocular pressure in adult patients with primary open-angle glaucoma. These procedures aim to improve aqueous humor drainage, reducing pressure within the eye.
Is the OMNI Surgical System intended for reuse or single-use per procedure?
The OMNI Surgical System is explicitly intended for single-use per procedure and must be disposed of after use. It is supplied as a reusable surgical instrument but is not sterile at shipment, requiring proper handling and disposal post-procedure to ensure patient safety.
How should the OMNI Surgical System be stored before use?
The device requires storage in a clean, dry environment as specified by the manufacturer. Since it is not sterile at shipment, it must be prepared for use according to the manufacturer’s instructions before clinical application.
Is the OMNI Surgical System compatible with MRI environments?
No, the OMNI Surgical System is not MRI-safe. This means it should not be used or stored in proximity to MRI machines, as exposure could pose risks to both the device and patients undergoing MRI procedures.
What regulatory pathway was followed for FDA clearance of the OMNI Surgical System?
The OMNI Surgical System received FDA 510(k) clearance (K173332) under the Traditional review pathway, demonstrating substantial equivalence to existing predicate devices. It is classified as a Class II medical device and adheres to regulatory standards outlined in 21 CFR 880.5725, intended for use in general hospital settings.
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 (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173332 | Class II | Active |
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Manufacturer
- Manufacturer
- Sight Sciences, Inc.
Sources (1)
- FDA 510(k) K173332 24 fields · synced Sep 19, 2026