Duns Number:654386890
Device Description: Structure: composed of optical imaging system, control system and display. Working princi Structure: composed of optical imaging system, control system and display. Working principle: AUTO REF/KERATOMETER is to use infrared fundus reflex phase method, by launching a specific wavelength beam of infrared light, through the examiner cornea, lens and so on, finally projected onto the retina eyeball, then reflected back to the corresponding optical system, absorb the image by image sensor, after image processing, signal processing, calculate the ball lens diopter, axial column lens dioptre, column mirror, An instrument used to determine the refractive state of the human eye. AUTO REF/KERATOMETER can move in X axis, Y axis and Z axis at the same time, with 3D automatic eye tracking function.
Catalog Number
-
Brand Name
AUTO REF/KERATOMETER
Version/Model Number
ARK-910
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HKO
Product Code Name
Refractometer, Ophthalmic
Public Device Record Key
8200e49a-759e-4049-bfd2-aa96df0f71f2
Public Version Date
November 11, 2021
Public Version Number
1
DI Record Publish Date
November 03, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |