The Auto Ref-Topographer HRKT-1 measures the light reflected from the retina using an MLA (Micro Lens Array) to provide information on the refractive power of the eye, and measures the…
The Auto Ref-Topographer HRKT-1 measures the light reflected from the retina using an MLA (Micro Lens Array) to provide information on the refractive power of the eye, and measures the curvature of the cornea and its defects by measuring the size of the image reflected from the cornea and testing for dry eye.
Who Else Makes It
Concentrated in Beijing (1), Shanghai (1), Chongqing (1).
Record
Regulatory record for Auto Ref-Topographer HRKT-1 | Listed by | Huvitz Co., Ltd., South Korea |
| FDA product code | MMQ |
| Device type | Topographer, Corneal, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1350 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-01-30 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Label carries | manufacturing date, 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.