QPB · System, Suction, Lipoplasty For Removal
General, Plastic Surgery · 21 CFR 878.5040 · Class 2
Overview
| Product Code | QPB |
|---|---|
| Device Name | System, Suction, Lipoplasty For Removal |
| 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 56)
Showing 20 most recent of 56 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252495 | LSSA (NP-200) | Newpong Co., Ltd. | Apr 3, 2026 | SESE |
| K244050 | AYON Body Contouring System (AYON SYSTEM) | Apyx Medical Corporation | May 12, 2025 | SESE |
| K244026 | PAL 7020 Console | Microaire Surgical Instruments, LLC | Apr 25, 2025 | SESE |
| K242804 | PAL Aspiration System | Microaire Surgical Instruments, LLC | Dec 30, 2024 | SESE |
| K241835 | AirSculpt Body Contouring System (AIRS-1-SYS) | Cellmyx | Nov 27, 2024 | SESE |
| K240188 | Vitruvian Liposaber | Black & Black Surgical, Inc. | Sep 13, 2024 | SESE |
| K212969 | Liposaver | Lhbiomed Co., Ltd. | Aug 7, 2024 | SESE |
| K220318 | PAL Infiltration System | Microaire Surgical Instruments, LLC | Oct 14, 2022 | SESE |
| K212024 | PAL System | Microaire Surgical Instruments, LLC | Jun 10, 2022 | SESE |
| K192694 | PAL Single-Use Cannulas | Microaire Surgical Instruments | May 14, 2020 | SESE |
| K200168 | Dermapose Access | Puregraft, LLC | Apr 22, 2020 | SESE |
| K190555 | PowerX Lipo System | Solta Medical | May 1, 2019 | SESE |
| K190551 | VASERlipo System | Solta Medical | May 1, 2019 | SESE |
| K171286 | PAL Multi-Use Cannulas and PAL Manual Wand | Microaire Surgical Instruments, LLC | Oct 13, 2017 | SESE |
| K170629 | VITRUVIAN INFILTRATION PUMP | Black & Black Surgical, Inc. | Jun 22, 2017 | SESE |
| K170329 | Basic, Dominant Flex | Modela AG | Mar 24, 2017 | SESE |
| K161722 | VITRUVIAN ULTIMATE ASPIRATOR | Black & Black Surgical, Inc. | Jul 26, 2016 | SESE |
| K150134 | Basic, Dominant Flex, KV-6 | Medela AG | Apr 21, 2015 | SESE |
| K132353 | SUCTION LIPOPLASTY ACCESSORIES | Inex | Jul 30, 2014 | SESE |
| K121218 | HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE REUSABLE CANNULA, 4MM DIA, | Andrew Technologies, LLC | Dec 13, 2012 | SESE |
Top Applicants
- Microaire Surgical Instruments, LLC — 6 clearances
- Black & Black Surgical, Inc. — 3 clearances
- Byron Medical — 3 clearances
- Sound Surgical Technologies, LLC — 3 clearances
- Andrew Technologies, LLC — 2 clearances
