Duns Number:317138956
Device Description: The Myopia Master combines different measuring functions in one unit.The Auto-Refractomete The Myopia Master combines different measuring functions in one unit.The Auto-Refractometer calculates the ametropia in D, the Keratometer determines the curvature of the cornea. The axial length of the eye is measured and displayed by interferometry.
Catalog Number
-
Brand Name
Myopia Master
Version/Model Number
68120
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
K202989
Product Code
MXK
Product Code Name
Device, Analysis, Anterior Segment
Public Device Record Key
c30c5e7c-33bb-47d3-80db-a8874ef56df2
Public Version Date
November 11, 2021
Public Version Number
1
DI Record Publish Date
November 03, 2021
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 |