Duns Number:002347102
Device Description: Light therapy acne mask
Catalog Number
-
Brand Name
Neutrogena
Version/Model Number
00070501302743
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
K123999
Product Code
OLP
Product Code Name
Over-the-counter powered light based laser for acne
Public Device Record Key
4897f177-a086-42ca-bb26-85a219152365
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 11, 2017
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 307 |
2 | A medical device with a moderate to high risk that requires special controls. | 10 |