Duns Number:533127663
Device Description: The Venus Legacy device is intended for the treatment of the following medical conditions The Venus Legacy device is intended for the treatment of the following medical conditions; usingthe applicators for delivery of non-thermal RF combined with massage and magneticfield pulses:• Relief of minor muscle aches and pain, relief of muscle spasm• Temporary improvement of local blood circulation• Temporary reduction in the appearance of cellulite
Catalog Number
-
Brand Name
LB1 applicator
Version/Model Number
AS100006
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
K143554,K191528,K143554,K191528
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
9ee752ae-9430-47a0-a95d-2d5b0f545cb8
Public Version Date
June 16, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
07290016540147
Quantity per Package
1
Contains DI Package
07290016540024
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 55 |