QKL · Lipoaspirate Washing System For Aesthetic Body Contouring
General, Plastic Surgery · 21 CFR 878.5040 · Class 2
Overview
| Product Code | QKL |
|---|---|
| Device Name | Lipoaspirate Washing System For Aesthetic Body Contouring |
| 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 (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| BK261326 | Viality™ Lipoaspirate Wash System for Aesthetic Body Contouring (Viality-1400) | Tiger Aesthetics Medical, LLC Franklin, Wisconsin 53132 | May 13, 2026 | SESE |
| BK251296 | PUREGRAFT SYNC Adipose Filtration System | Bimini Health Tech Plano, TX 75024 | Feb 12, 2026 | SESE |
| BK251197 | “HsingChi” LipoSelector Disposable Fat Collection System (LS-1200) | HsingChi Medical Ltd. TAIWAN | Dec 23, 2025 | SESE |
| BK251268 | Synova Wave Adipose Processing System | Synova Life Sciences, Inc. Los Angeles, CA 90032 | Nov 17, 2025 | SESE |
| BK251199 | NLF system® kit 2 (EUROMI) | EUROMI S.A Belgium | Aug 14, 2025 | SESE |
| BK231013 | LipoGrafter® Kit | Musculoskeletal Transplant Foundation (MTF Biologics) Edison, NJ | May 16, 2024 | SESE |
| BK220668 | VorFat System | Alma Lasers, Inc. | Jun 12, 2023 | SESE |
Top Applicants
- Alma Lasers, Inc. — 1 clearance
- Bimini Health Tech Plano, TX 75024 — 1 clearance
- EUROMI S.A Belgium — 1 clearance
- HsingChi Medical Ltd. TAIWAN — 1 clearance
- Musculoskeletal Transplant Foundation (MTF Biologics) Edison, NJ — 1 clearance
