Duns Number:533127663
Device Description: The Venus Bliss device is a diode laser system intended for non-invasive lipolysis of the The Venus Bliss device is a diode laser system intended for non-invasive lipolysis of the abdomenand flanks in individuals with a Body Mass Index (BMI) of 30 or less.In addition, the Venus Bliss device is intended for the treatment of the following medicalconditions; using the MP2 applicator for delivery of RF energy combined with massage andmagnetic field 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
BLISS SYSTEM
Version/Model Number
BL000001
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
K190743,K190743
Product Code
PBX
Product Code Name
Massager, Vacuum, Radio Frequency Induced Heat
Public Device Record Key
670feab4-666c-4e62-971b-51ea8e482808
Public Version Date
July 22, 2021
Public Version Number
1
DI Record Publish Date
July 14, 2021
Package DI Number
07290016541632
Quantity per Package
1
Contains DI Package
07290016541281
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 |