Duns Number:690635461
Device Description: The AUTO REF/KERATOMETER ARK-F is a medical device which measures objective refractive err The AUTO REF/KERATOMETER ARK-F is a medical device which measures objective refractive errors and corneal curvature radius of the patient’s eye. This device also offers retroillumination mode for observing the condition of the ocular media, and measures the amplitude of accommodation.
Catalog Number
-
Brand Name
AUTO REF/KERATOMETER
Version/Model Number
ARK-F
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
0a10cbd8-a5de-4a6b-804f-44b63d52287a
Public Version Date
December 21, 2020
Public Version Number
4
DI Record Publish Date
February 22, 2019
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 | 39 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 73 |
| 3 | A medical device with high risk that requires premarket approval | 5 |