Duns Number:514891048
Device Description: The Silk'n device ia an over-the-counter, non-invasive, non-ablative device utilizing RF a The Silk'n device ia an over-the-counter, non-invasive, non-ablative device utilizing RF and optical LED energies for the treatment of wrinkles.
Catalog Number
7290112450227
Brand Name
Silk'n
Version/Model Number
BellaVisage
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
96e65e92-4c1f-40bf-ab2f-cdfa3dc450e9
Public Version Date
November 23, 2020
Public Version Number
4
DI Record Publish Date
October 18, 2018
Package DI Number
27290112450221
Quantity per Package
4
Contains DI Package
17290112450224
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |