Visionix
4 catalogue numbers from PRISM BARS SET (HORIZ. + VERT) + 2 add p, listed by Luneau Technology Operations, France, under Prism, Bar, Ophthalmic. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Beijing (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuxi Zontai Int’l Corporation Ltd. | Wuxi | Jiangsu | Contract manufacturer | 22 |
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
| Shanghai Canton Optics Equipment Co., Ltd. | Shanghai | Shanghai | Manufacturer | 14 |
| Jiangsu Liangxu Intelligence Science AND Technology Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 12 |
Record
| Listed by | Luneau Technology Operations, France |
|---|---|
| FDA product code | HKW |
| Device type | Prism, Bar, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1650 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-06-08 |
| Record revised | 2025-01-15 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PRISM BARS SET (HORIZ. + VERT) + 2 add prisms 40 and 30 dpt | In distribution | |
| Prism Bar Set horiz./vertical | In distribution | |
| Prism Bar horizontal | In distribution | |
| Prism Bar vertical | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Optego | Optego Vision USA, Inc. | 48 |
| Clement Clarke Ophthalmic | Haag-Streit UK Ltd. | 1 |
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.