iPRIME
Viscodelivery System
2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 | Glaukos Corporation, United States |
|---|---|
| FDA product code | MRH |
| Device type | Pump, Infusion, Ophthalmic |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5725 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2022-05-13 |
| Record revised | 2026-01-13 (version 2) |
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 | 2025-03-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VCP100 | Withdrawn |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 |
| Omni Surgical System (US) | Sight Sciences, Inc. | 1 |
| TrabEx Pro | Microsurgical Technology, Inc. | 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 |
|---|---|
| K212797 | 2022-01-06 |
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.