Duns Number:514905681
Device Description: LEGEND PRO PACKEDApplicators 1-3 provide RF energy that heats biological tissue in a contr LEGEND PRO PACKEDApplicators 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. 1 is indicated for the treatment of large facial areas. It is connected to the main unit by a cable containing electrical wiring and a connector, consists of a plastic body with an integrated electronic system, 6 electrodes and indication light guide ring.
Catalog Number
30020000U
Brand Name
Legend Pro
Version/Model Number
Legend Pro
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
K173503
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
0dc4f0c3-4b91-43cb-b59c-56b5c6464550
Public Version Date
May 20, 2019
Public Version Number
1
DI Record Publish Date
May 12, 2019
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 |