Duns Number:849862912
Device Description: This light therapy beauty tool attacks blemishes at its core without the need for oral med This light therapy beauty tool attacks blemishes at its core without the need for oral medications
Catalog Number
DPA-002-PK
Brand Name
Baby Blue Pink
Version/Model Number
DPA-002-PK
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
18dca984-2376-462d-b95f-b5a106fe9775
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 |