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. This is a tester device.
Catalog Number
HU-FG01821
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
a3f09b0b-84de-41ad-b384-096e41ab4fda
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 10, 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 |