Duns Number:338702316
Device Description: EIDON AF (Eidon from Greek eidou, “to see” and AF, AutoFluorescence) is a scanning ophthal EIDON AF (Eidon from Greek eidou, “to see” and AF, AutoFluorescence) is a scanning ophthalmoscope which uses infrared and visible light to obtain confocal infrared reflectance images, confocal visible reflectance images of the retina and fluorescence images of the retina, without pharmacological dilation.EIDON is a standalone device.
Catalog Number
AIFLUME001
Brand Name
EIDON
Version/Model Number
EIDON AF
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
K142047
Product Code
MYC
Product Code Name
Ophthalmoscope,Laser,Scanning
Public Device Record Key
b241e6b3-98a3-49cc-b00c-31360e8bca43
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
July 29, 2016
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |