AMA Optics Occluder
A hand-operated, non-powered ophthalmic device intended to temporarily prevent and/or attenuate the passage of light (vision) to the eye(s) during an eyesight examination (e.g.,…
A hand-operated, non-powered ophthalmic device intended to temporarily prevent and/or attenuate the passage of light (vision) to the eye(s) during an eyesight examination (e.g., diagnosis/measurement of heterophoria/heterotropia, myopia). The part of the device used to cover the eye(s) is typically spoon- or oval-shaped, and may be fully opaque or incorporate small holes and/or a Maddox lens(es) [i.e., coloured lens(es)]; the device also incorporates a handle and/or binocular frame. This is a reusable device.
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (2), Beijing (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Taiyuan North China Xinyuan Tech. Center (Co., Ltd.) | Taiyuan | Shaanxi | Contract manufacturer | 14 |
| Update Optical Manufacturer Limited | Longgang District, Shenzhen | Guangdong | Contract manufacturer | 3 |
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Danyang NEW Hope Medical Equipment Co., Ltd. | Danyang | Jiangsu | Manufacturer | 38 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
| Wuxi Zontai Int’l Corporation Ltd. | Wuxi | Jiangsu | Contract manufacturer | 22 |
| Shanghai Link Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 21 |
| Gino Optical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Manufacturer | 15 |
| Shanghai Canton Optics Equipment Co., Ltd. | Shanghai | Shanghai | Manufacturer | 14 |
| Jiangsu Liangxu Intelligence Science AND Technology Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 12 |
| Wenzhou Hala Trade Co., Ltd. | Wenzhuo | Zhejiang | Manufacturer | 7 |
Showing 12 of 13. All 13 manufacturers in China registered for Set, Lens, Trial, Ophthalmic
Record
| Listed by | AMA Optics, Inc., United States |
|---|---|
| FDA product code | HPC |
| Device type | Set, Lens, Trial, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1405 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-08-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| O-MAGNETIC | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bernell | Bernell | 175 |
| Optego | Optego Vision USA, Inc. | 66 |
| Fresnel Prism AND Lens | Fresnel Prism & Lens Co. | 32 |
| Tiannuo / Tnmed | Lianyungang Tiannuo Optical Instrument Co., Ltd. | 9 |
| Rexxam | Rexxam.co., Ltd. | 2 |
| BK S2, wooden case with handle | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| BK 2, coated, wooden case with handle | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| BK S1/T without convex cylinders, coated table version, trial lens case | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| BK 2, without convex cylinders, wooden case with handle | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| BK X/O (according to Kochniss), without convex cylinders, coated, inclusive tria | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| BK S3, wooden lens case with handle | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| Prism Lens Case, coated | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
Showing 12 of 39. All products under Set, Lens, Trial, Ophthalmic
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.