The NIDEK refractive power / corneal analyzer OPD-Scan III (hereafter referred to as “the device”) measures objective refractive error, corneal curvature, shape of the anterior corneal…
The NIDEK refractive power / corneal analyzer OPD-Scan III (hereafter referred to as “the device”) measures objective refractive error, corneal curvature, shape of the anterior corneal surface (topography), and pupil size of the patient’s eye, and analyzes wavefront aberration. The measured refractive error can be used for reference when prescribing corrective lenses such as glasses or contact lenses.
Who Else Makes It
All of them in Jiangsu.
Record
Regulatory record for Refractive Power / Corneal Analyzer | 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 | 2016-08-19 |
| 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.