Duns Number:514891048
Device Description: An over the counter device intended for the removal of unwanted hair. Also intended for pe An over the counter device intended for the removal of unwanted hair. Also intended for permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of treatment regime.The electric output is indicated for facial stimulation for over-the-counter aesthetic use.
Catalog Number
7290015764759
Brand Name
Silk'n
Version/Model Number
Infinity
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
NFO
Product Code Name
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Public Device Record Key
f7bed42b-c92d-450f-9c06-cfa073b1d47b
Public Version Date
November 23, 2020
Public Version Number
7
DI Record Publish Date
January 25, 2018
Package DI Number
27290015764753
Quantity per Package
6
Contains DI Package
17290015764756
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 |