The NIDEK AUTO REF/KERATOMETER ARK-1s measures spherical, cylindrical refractive errors, and cylinder axis from the refractive status of the patient’s eye. In addition, subjective test is…
The NIDEK AUTO REF/KERATOMETER ARK-1s measures spherical, cylindrical refractive errors, and cylinder axis from the refractive status of the patient’s eye. In addition, subjective test is performed with the built-in charts and lenses for subjective measurement. The keratometer measures the corneal curvature radius (corneal refractive power), principal meridian directions, and corneal cylindrical power.
Who Else Makes It
All of them in Jiangsu.
Record
Regulatory record for Auto REF/Keratometer | Listed by | Nidek Incorporated, United States |
| FDA product code | HLQ |
| Device type | Keratoscope, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1350 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-08-10 |
| Record revised | 2020-12-21 (version 5) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | serial 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.