Duns Number:493246808
Device Description: The DemarkQ is an Over-the-Counter (OTC) device intended for treatment of mild to moderate The DemarkQ is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.
Catalog Number
-
Brand Name
DemarkQ
Version/Model Number
P19-0007
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
K203214
Product Code
OLP
Product Code Name
Over-The-Counter Powered Light Based Laser For Acne
Public Device Record Key
3eb2d520-cd76-4dfb-a50a-e0eaa144ad10
Public Version Date
April 11, 2022
Public Version Number
1
DI Record Publish Date
April 01, 2022
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. | 1 |