Duns Number:317138956
Device Description: While rotating around the eye, the Pentacam® AXL captures Scheimpflugimages of the anterio While rotating around the eye, the Pentacam® AXL captures Scheimpflugimages of the anterior eye segment through varying axes. TheScheimpflug images created during an examination are transmitted tothe connected PC.The axial length of the eye is measured and displayed by interferometry.
Catalog Number
-
Brand Name
Pentacam AXL
Version/Model Number
70100
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
K152311
Product Code
MXK
Product Code Name
Device,Analysis,Anterior Segment
Public Device Record Key
374409a5-8836-4852-b570-f51c7a7e4866
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 01, 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |