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
All of them in Jiangsu.
Record
Regulatory record for AMA Optics Occluder | Listed by | AMA Optics, Inc., United States |
| FDA product code | HPB |
| Device type | Clip, Lens, Trial, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1410 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-08-01 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Label carries | lot or batch number |
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.