Duns Number:864213893
Device Description: OVITZ P10 is an ophthalmic aberrometer. It uses Wavefront Sensing technology for accurate OVITZ P10 is an ophthalmic aberrometer. It uses Wavefront Sensing technology for accurate and reliable refractive measurements in human eyes. It is compact and completely portable, with a light weight body and long-lasting battery. It has a high resolution, touchscreen color display. An ergonomic handle gives the user a comfortable control in handling of the device.
Catalog Number
-
Brand Name
Ovitz Aberrometer
Version/Model Number
P10
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
HKO
Product Code Name
Refractometer, Ophthalmic
Public Device Record Key
fd9566d5-2550-45f9-9df8-5114e5d7ae04
Public Version Date
December 21, 2020
Public Version Number
3
DI Record Publish Date
August 22, 2019
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |