Duns Number:514905681
Device Description: Applicators 1-3 provide RF energy that heats biological tissue in a controlled fashion for Applicators 1-3 provide RF energy that heats biological tissue in a controlled fashion for non-ablative therapeutic effects. Non ablative effects are used to trigger collagen remodeling for the treatment of wrinkles and rhytides. Applicator No.2 is indicated for the treatment of medium size facial areas. It is connected to the main unit by a cable containing electrical wiring and a connector, also consisting of a plastic body with integrated electronic system, 3 electrodes and indication light guide ring.
Catalog Number
21400270
Brand Name
POLLOGEN LEGEND
Version/Model Number
POLLOGEN LEGEND+
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K111026
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
f1b35f21-725e-433c-902b-786d609ca17b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 06, 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. | 19 |