MUU · System, Suction, Lipoplasty
General, Plastic Surgery · 21 CFR 878.5040 · Class 2
Overview
| Product Code | MUU |
|---|---|
| Device Name | System, Suction, Lipoplasty |
| Regulation | 21 CFR 878.5040 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of 1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.
Classification Rationale
Class II (special controls). Consensus standards and labeling restrictions.
Special Controls
*Classification.* Class II (special controls). Consensus standards and labeling restrictions.
Recent Cleared Devices (20 of 40)
Showing 20 most recent of 40 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K210528 | IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit | Millennium Medical Technologies Inc (Dba Cellmyx) | Mar 16, 2022 | SESE |
| K203800 | SyntrFuge System | Syntr Health Technologies, Inc. | Jul 2, 2021 | SESE |
| K202443 | Smart Kit Basic, Smart Kit Pro | Bsl Co., Ltd. | Mar 11, 2021 | SESE |
| K193539 | REVOLVE ENVI 600 Advanced Adipose System | Lifecell Corporation | May 28, 2020 | SESE |
| K193363 | Dermapose Refresh | Puregraft, LLC | Apr 14, 2020 | SESE |
| K182732 | JTL-250-01 | Jointechlabs, Inc. | Nov 18, 2019 | SESE |
| K191564 | Progenikine Concentrating System 25 mL System | Emcyte Corporation | Nov 7, 2019 | SESE |
| K190386 | KTA Adipose Treatment Kit | Stemics S.A.S | Oct 10, 2019 | SESE |
| K190278 | AuraGen 123 Suction Lipoplasty System (A123) | Auragen Aesthetics, LLC | May 3, 2019 | SESE |
| K172717 | Automatic Tissue Processing Unit | Bsl Co. | May 25, 2018 | SESE |
| K172714 | LipiVage | Genesis Biosystems, Inc. | Dec 8, 2017 | SESE |
| K163647 | Revolve Envi 600 Advanced Adipose System | Lifecell Corporation | Aug 25, 2017 | SESE |
| K171242 | Alma LipoFlow System | Alma Lasers, Inc. | Jul 14, 2017 | SESE |
| K171135 | Lipogems System | Lipogems International Spa | May 18, 2017 | SESE |
| K170449 | Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection | Millennium Medical Technologies, Inc. | Mar 31, 2017 | SESE |
| K161372 | The Red Head Collection Device, The Jordy Connection System | Miami Fat Supply | Feb 24, 2017 | SESE |
| K162932 | Ranfac Fat Aspiration Cannula | Ranfac, Corp. | Jan 19, 2017 | SESE |
| K161636 | Lipogems System | Lipogems International Spa | Nov 4, 2016 | SESE |
| K150156 | Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel | Ranfac, Corp. | Oct 19, 2015 | SESE |
| K150779 | LipoFilter - Hospital Pack, LipoFilter - Clinic Pack | Microaire Surgical Instruments, LLC | May 22, 2015 | SESE |
Top Applicants
- Cytori Therapeutics, Inc. — 4 clearances
- Lipogems International Spa — 3 clearances
- Shippert Medical Technologies Corp. — 2 clearances
- Ranfac, Corp. — 2 clearances
- Medi-Khan USA, Inc. — 2 clearances
