Duns Number:320405061
Device Description: The "Liposat Pro plus" is a pump that is used in the field of aesthetic body contouring.Th The "Liposat Pro plus" is a pump that is used in the field of aesthetic body contouring.The "Liposat Pro plus" is used to promote aqueous solutions for the production of tumescence local anesthesia as well as body-own, subcutaneous tissue and its components in the body.The pump "Liposat Pro plus" may only be used with the tube set "TLA Tubing Liposat Pro plus" and "Fat Tubing Liposat Pro plus" of the the Möller Medical GmbH.
Catalog Number
-
Brand Name
Liposat Pro plus
Version/Model Number
00003974
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
MUU
Product Code Name
System, Suction, Lipoplasty
Public Device Record Key
8b3fb72a-d1e0-43e1-8885-980ee9fdc4b7
Public Version Date
January 29, 2020
Public Version Number
1
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 |