Omni Plus
OMNI PLUS Surgical System
2manufacturers in China registered for this device type
1catalogue number
8510(k) clearances naming this product code
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) | K201953 |
| Record published | 2020-10-30 |
| Record revised | 2024-01-03 (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 | 2023-10-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1-104 | Withdrawn |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 |
| iPRIME | Glaukos Corporation | 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.