Duns Number:317138956
Device Description: The Corvis® ST is a non-contact tonometer equipped with an opticalPachymetry function.The The Corvis® ST is a non-contact tonometer equipped with an opticalPachymetry function.The Corvis® ST measures intraocular pressure without contact with the eyeby applying an air puff to the eye. During the air puff the eye getsilluminated by a 9 mm slit through the apex and a built-in high-speedcamera records the movement of the eye with more than 4000 images persecond.The high-speed camera uses a sequence of 140 Scheimpflug images of thecornea which are analyzed by a built-in computer.Intra ocular pressure is determined by the detection of the applanationmoments of the cornea.
Catalog Number
-
Brand Name
Corvis STL
Version/Model Number
72300
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
K113066
Product Code
HKX
Product Code Name
Tonometer, Ac-Powered
Public Device Record Key
42c8b831-8fcf-482b-a101-ecb6aa97f1db
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 |