An ophthalmic device for binocular vision testing. The patient views a two image pairs stacked (Top = right dim image/left bright image; Bottom = right bright image//left dim image) through…
An ophthalmic device for binocular vision testing. The patient views a two image pairs stacked (Top = right dim image/left bright image; Bottom = right bright image//left dim image) through polarizing glasses of a polarizing system and informs the examining doctor when the combination perceived changes. This visual impression provides the information whereby a diagnosis of unconscious suppression of one eye can be determined.
Who Else Makes It
Registered in Jiangsu.
Record
Regulatory record for AMA Optics Amblyometer | Listed by | AMA Optics, Inc., United States |
| FDA product code | HLC |
| Device type | Instrument, Measuring, Stereopsis |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1460 |
| 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.