Duns Number:690635461
Device Description: The F-10 captures and records the confocal images of fundus by laser scanning using a sele The F-10 captures and records the confocal images of fundus by laser scanning using a selection of laser colors: IR (infrared), blue, green, and red. Indocyanine green (ICG) angiography and fluorescein angiography (FAG) are also possible.
Catalog Number
-
Brand Name
OPHTHALMOSCOPE
Version/Model Number
F-10
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
MYC
Product Code Name
Ophthalmoscope, Laser, Scanning
Public Device Record Key
3091c2ad-24bd-4c94-b662-9f7c14c6c796
Public Version Date
May 21, 2018
Public Version Number
1
DI Record Publish Date
April 20, 2018
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 |