Duns Number:320405061
Device Description: Liposat Pro is a pump that is used in the field of aesthetic body contouring.The "Liposat Liposat Pro is a pump that is used in the field of aesthetic body contouring.The "Liposat Pro" is used to promote aqueous solutions for the production of tumescence local anaesthesia in the body.The tumescence pump "Liposat Pro" may only be used with the tube set "Tube set for Liposat Power" from the Möller Medical GmbH.
Catalog Number
-
Brand Name
Liposat Pro
Version/Model Number
00003977
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K053451
Product Code
QPB
Product Code Name
System, Suction, Lipoplasty For Removal
Public Device Record Key
b67689ab-9655-4a89-97be-b6e787c4e527
Public Version Date
March 30, 2022
Public Version Number
2
DI Record Publish Date
January 21, 2020
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 398 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 324 |