Duns Number:849862912
Device Description: The Quasar Professional Blue Light Therapy device will help your clients gain control over The Quasar Professional Blue Light Therapy device will help your clients gain control over blemishes and occasional breakouts. Intended for use with hormonal acne or acne vulgaris, the light effectively eliminates the acne bacteria that causes breakouts.
Catalog Number
DPA-006A
Brand Name
Professional Blue
Version/Model Number
DPA-006A
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
K093963
Product Code
OLP
Product Code Name
Over-The-Counter Powered Light Based Laser For Acne
Public Device Record Key
6c9dc862-68f0-4a6c-9c63-7341b5ea4372
Public Version Date
July 07, 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 |