Duns Number:248047115
Device Description: Home use, hand held, rechargeable red light (660nm ) LED emitting device that is used for Home use, hand held, rechargeable red light (660nm ) LED emitting device that is used for the treatment of wrinkles, rhytides and fine lines in the periorbital region
Catalog Number
HU-FG01881
Brand Name
Me
Version/Model Number
Series 15
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
OHS
Product Code Name
Light Based Over The Counter Wrinkle Reduction
Public Device Record Key
127252ad-fd11-4c02-aed6-1c01cf508451
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 23, 2017
Package DI Number
10806248007569
Quantity per Package
3
Contains DI Package
00806248007562
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |