Duns Number:649726981
Device Description: The sensiLift is an over-the-counter home use device intended for non-invasive treatment o The sensiLift is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick Skin Types I-IV.
Catalog Number
-
Brand Name
sensiLift
Version/Model Number
ST100US01SNS
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
K170499
Product Code
PAY
Product Code Name
Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
Public Device Record Key
3bfff1f2-3075-42d6-bca3-8c99adfd9d19
Public Version Date
February 07, 2020
Public Version Number
4
DI Record Publish Date
August 16, 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 |