Duns Number:248047115
Device Description: Home use, hand held, rechargeable blue light (414nm ) LED emitting device that is used for Home use, hand held, rechargeable blue light (414nm ) LED emitting device that is used for the treatment of mild to moderateinflammatory acne. This is a store display.One device count includes 1 tester and 6 units.
Catalog Number
HU-CO00821
Brand Name
Me
Version/Model Number
Series 14
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
-
Product Code
OLP
Product Code Name
Over-The-Counter Powered Light Based Laser For Acne
Public Device Record Key
24fda591-6bf4-4621-9346-b461c0e20de2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 25, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |