Duns Number:043184204
Device Description: Polarized Illumination System with magnification for enhanced visualization during dermato Polarized Illumination System with magnification for enhanced visualization during dermatology and cosmetic procedures.
Catalog Number
-
Brand Name
v900L Vision System
Version/Model Number
v900L
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 15, 2020
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KZF
Product Code Name
Device, Medical Examination, Ac Powered
Public Device Record Key
fe925452-c9d9-4246-97da-47bf3903d0b6
Public Version Date
July 17, 2020
Public Version Number
3
DI Record Publish Date
December 04, 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 | 2 |