Omni Surgical System (US)
The OMNI Surgical System is a manually operated instrument for delivery of small amounts of viscoelastic fluid during eye surgery. Ophthalmologists also use it to cut trabecular meshwork…
The OMNI Surgical System is a manually operated instrument for delivery of small amounts of viscoelastic fluid during eye surgery. Ophthalmologists also use it to cut trabecular meshwork during trabeculotomy procedures.
The handheld device contains a cannula, microcatheter, fluid reservoir, plunger tube and finger wheels. Turning the wheels advances or retracts the microcatheter. During viscoelastic delivery, retraction moves the plunger into the reservoir and dispenses fluid.
Delivery Limits
The microcatheter travels up to 20 mm per cycle and supports up to five full cycles. Viscoelastic delivery occurs only during the first two cycles. The device is supplied sterile for a single use.
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Peter’s Technology (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Record
| Listed by | Sight Sciences, Inc., United States |
|---|---|
| FDA product code | MRH |
| Device type | Pump, Infusion, Ophthalmic |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K173332 |
| Record published | 2019-10-25 |
| Record revised | 2023-08-22 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2019-10-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FG 05757 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Viscous Fluid Pack | Escalon Medical Corp | 2 |
| Streamline Surgical System | New World Medical, Inc. | 2 |
| Omni Surgical System | Sight Sciences, Inc. | 2 |
| TrabEx Pro | Microsurgical Technology, Inc. | 1 |
| iPRIME | Glaukos Corporation | 1 |
| Omni Plus | Sight Sciences, Inc. | 1 |
| VIA360 Surgical System | New World Medical, Inc. | 1 |
| ViscoInjector | Nova EYE Inc. | 1 |
| VISCO(TM)360 Viscosurgical System | Sight Sciences, Inc. | 1 |
| Omni Edge Surgical System | Sight Sciences, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253760 | 2026-08-04 |
| K232214 | 2023-08-25 |
| K202678 | 2021-03-01 |
| K201953 | 2020-08-11 |
| K173332 | 2017-12-21 |
| K171905 | 2017-07-27 |
| K143205 | 2014-12-05 |
| K132494 | 2013-10-22 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.