Duns Number:849862912
Device Description: The Quasar Professional Red Light Therapy device enables you to provide essential treatmen The Quasar Professional Red Light Therapy device enables you to provide essential treatments to rebuild clients’ collagen and elastin. Smooth the skin and reduce wrinkles with the most powerful tools available outside the doctors’ offices.
Catalog Number
DPA-004Red
Brand Name
Professional Red
Version/Model Number
DPA-004Red
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K130225
Product Code
OHS
Product Code Name
Light Based Over The Counter Wrinkle Reduction
Public Device Record Key
6f132942-7ec4-4516-8cc0-7298b0f2fcc5
Public Version Date
February 24, 2020
Public Version Number
4
DI Record Publish Date
September 19, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |