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 a long-term, stable reduction in hair counts following a treatment regime.
Catalog Number
7290016627855
Brand Name
Silk'n
Version/Model Number
Flash & Go LUXX
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
OHT
Product Code Name
Light Based Over-The-Counter Hair Removal
Public Device Record Key
2a5ac58e-eadc-49a5-a229-12ee515662e5
Public Version Date
November 16, 2020
Public Version Number
7
DI Record Publish Date
January 25, 2018
Package DI Number
27290016627859
Quantity per Package
4
Contains DI Package
17290016627852
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 |