Identity
- Trade Name
- Vacusat power FDA UDI
- Generic Name
- Liposuction system FDA UDI
- Device Name
- Vacusat power is a powerful, low-noise extraction unit designed for continuous operation and suitable for high flow and vacuum rates. It extracts tumescence solution, body fats, fat cells (secretion, blood and serous liquids) and contained particles from natural and artificial body orifices and is designed for patient surgical vacuum extraction and liposuction. Vacusat power is applied in the clinical field or in medical practices by trained personnel. Vacusat power is neither suitable in the Home Care area for direct application by the patient nor suitable as drainage extractor. Do not use the extractor in cardiac surgery or in surgery on the central nervous system. FDA UDI
- Model / Reference
- 00002318 FDA UDI
- Description
- Vacusat power is a powerful, low-noise extraction unit designed for continuous operation and suitable for high flow and vacuum rates. It extracts tumescence solution, body fats, fat cells (secretion, blood and serous liquids) and contained particles from natural and artificial body orifices and is designed for patient surgical vacuum extraction and liposuction. Vacusat power is applied in the clinical field or in medical practices by trained personnel. Vacusat power is neither suitable in the Home Care area for direct application by the patient nor suitable as drainage extractor. Do not use the extractor in cardiac surgery or in surgery on the central nervous system. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260277177461 FDA UDI
- 510(k) Number
- K053451 FDA UDI
- FDA Product Code
- QPB FDA UDI
- GMDN Term
- Liposuction system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Liposuction system
Vacusat power by Möller Medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Liposuction system.
- ORIGINS — Solta Medical, Inc. · Class II
- Hydrophobic Filter-set — Human Med AG · Class II
- MicroAire® — MicroAire Surgical Instruments LLC · Class II
- AYON Base Tower — Apyx Medical Corporation · Class II
- MicroAire® — MicroAire Surgical Instruments LLC · Class II
- ORIGINS — Solta Medical, Inc. · Class II
- Alma LipoFlow System 50Hz — ALMA LASERS LTD. · Class II
- AirSculpt Handpiece — Millennium Medical Technologies, Inc. · Class II
Cleared under the same submission
K053451 also covers:
- Injection cannula 3 — Möller Medical GmbH
- Liposat Pro — Möller Medical GmbH
- Liposat Pro plus — Möller Medical GmbH
- Liposat power infiltration pump — Möller Medical GmbH
- Tubing for tumescent pump "Liposat" — Möller Medical GmbH
- Vacusat power — Möller Medical GmbH
- Vibrasat Pro Console — Möller Medical GmbH
- Vibrasat Pro Wand — Möller Medical GmbH
- Vibrasat power — Möller Medical GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Möller Medical GmbH
Sources (1)
- FDA UDI 1bef586a-d716-4fba-bd23-5964f15d0f43 34 fields · synced Jun 9, 2026