Duns Number:849862912
Device Description: This light therapy prescription-strength powerhouse combines collagen-producing technology This light therapy prescription-strength powerhouse combines collagen-producing technology with a larger treatment head bringing the spa into your living room.
Catalog Number
DPA-024
Brand Name
Quasar MD Plus
Version/Model Number
DPA-024
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
2b6d5ea4-9eca-40f5-a042-851d5efa1c7b
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 |