Duns Number:692281073
Device Description: The KOWA DR-1α is an ocular surface interferometer, which is an ophthalmic imaging device The KOWA DR-1α is an ocular surface interferometer, which is an ophthalmic imaging device that is intended for use by physician in adult patients to observe and record a video image of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented.
Catalog Number
-
Brand Name
KOWA DR-1α
Version/Model Number
DE2K
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 10, 2019
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
K190573
Product Code
HKI
Product Code Name
Camera, Ophthalmic, Ac-Powered
Public Device Record Key
5cbf99cc-65a9-4e57-a9e9-448e178db7ad
Public Version Date
June 18, 2019
Public Version Number
1
DI Record Publish Date
June 10, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |