VIA360 Surgical System
The VIA360 Surgical System is a manually operated instrument for delivering controlled amounts of viscoelastic fluid during eye surgery. It is also used to cut trabecular meshwork during…
The VIA360 Surgical System is a manually operated instrument for delivering controlled amounts of viscoelastic fluid during eye surgery. It is also used to cut trabecular meshwork during trabeculotomy. The instrument combines a stainless steel cannula with a nylon microcatheter for work in the anterior segment of the eye.
Turning the scroll wheel advances or retracts the microcatheter, while pressing the wheel or surrounding button dispenses fluid through outlets near its tip. Markings at 10 mm intervals indicate the extended length. The catheter can travel up to 40 mm during a cycle.
Positioning and Preparation
A rotatable nose piece lets the cannula be oriented for use in either eye. An external reservoir is included for priming the instrument. The device is intended for single use by ophthalmologists.
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 | New World Medical, Inc., United States |
|---|---|
| FDA product code | MRH |
| Device type | Pump, Infusion, Ophthalmic |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K243503 |
| Record published | 2025-02-18 |
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, manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VIA360 | In distribution |
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 |
| Omni Surgical System (US) | Sight Sciences, Inc. | 1 |
| TrabEx Pro | Microsurgical Technology, Inc. | 1 |
| iPRIME | Glaukos Corporation | 1 |
| Omni Plus | Sight Sciences, 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 |
|---|---|
| K243503 | 2025-02-14 |
| K211680 | 2021-10-08 |
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.