Product code QPB
- Device name
- System, Suction, Lipoplasty For Removal
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.5040
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253396 | AYON Body Contouring System™ (AYON SYSTEM) | Apyx Medical Corporation | 2026-05-08 |
| K252495 | LSSA (NP-200) | Newpong Co., Ltd. | 2026-04-03 |
| K244050 | AYON Body Contouring System (AYON SYSTEM) | Apyx Medical Corporation | 2025-05-12 |
| K244026 | PAL 7020 Console | Microaire Surgical Instruments, LLC | 2025-04-25 |
| K242804 | PAL Aspiration System | Microaire Surgical Instruments, LLC | 2024-12-30 |
| K241835 | AirSculpt Body Contouring System (AIRS-1-SYS) | Cellmyx | 2024-11-27 |
| K240188 | Vitruvian Liposaber | Black & Black Surgical, Inc. | 2024-09-13 |
| K212969 | Liposaver | Lhbiomed Co., Ltd. | 2024-08-07 |
| K220318 | PAL Infiltration System | Microaire Surgical Instruments, LLC | 2022-10-14 |
| K212024 | PAL System | Microaire Surgical Instruments, LLC | 2022-06-10 |
| K192694 | PAL Single-Use Cannulas | Microaire Surgical Instruments | 2020-05-14 |
| K200168 | Dermapose Access | Puregraft, LLC | 2020-04-22 |
| K190555 | PowerX Lipo System | Solta Medical | 2019-05-01 |
| K190551 | VASERlipo System | Solta Medical | 2019-05-01 |
| K171286 | PAL Multi-Use Cannulas and PAL Manual Wand | Microaire Surgical Instruments, LLC | 2017-10-13 |
| K170629 | VITRUVIAN INFILTRATION PUMP | Black & Black Surgical, Inc. | 2017-06-22 |
| K170329 | Basic, Dominant Flex | Modela AG | 2017-03-24 |
| K161722 | VITRUVIAN ULTIMATE ASPIRATOR | Black & Black Surgical, Inc. | 2016-07-26 |
| K150134 | Basic, Dominant Flex, KV-6 | Medela AG | 2015-04-21 |
| K132353 | SUCTION LIPOPLASTY ACCESSORIES | Inex | 2014-07-30 |
| K121218 | HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE REUSABLE CANNULA, 4MM DIA, | Andrew Technologies, LLC | 2012-12-13 |
| K113128 | MICROAIRE SURGICAL INSTRUMENTS LLC | Microaire Surgical Instruments, LLC | 2012-08-17 |
| K113795 | SUCTION LIPOLASTY ACCESSORIES | Norman M. Black Iii | 2012-08-07 |
| K110306 | SOUND SURGICAL VASER 2.1 LIPO SYSTEM | Sound Surgical Technologies, LLC | 2011-06-23 |
| K110255 | SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM | Sound Surgical Technologies, LLC | 2011-04-04 |
| K101413 | EUROMI EVA SP6 | Euromi S.A | 2010-12-16 |
| K092066 | PHASER LIPOPLASTY SYSTEM (DUR-01), PHASER DISPOSABLE KIT (DIS-01), PHASER WASTE COLLECTION KIT (WAS-01), PHASER CANNULAE | Andrew Technologies, LLC | 2010-04-12 |
| K093067 | LIPOSE DISPOSABLE CANNULA | Lipose Corp. | 2009-12-29 |
| K082025 | BODY-JET | Human Med AG | 2008-08-13 |
| K081593 | POWER ASPIRATOR, MODEL LS2 OR LS2DP | Medical Device Resource Corp. | 2008-07-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840329838225 | BLACK & BLACK SURGICAL, INC. | BLACK & BLACK SURGICAL, INC. | 2026-06-08 |
| 07612367000109 | Silicone tubing ID 6.5mm, 180cm, 1 coupling piece | Medela AG | 2024-05-31 |
| 07612367003902 | Tubing holder right side | Medela AG | 2024-05-31 |
| 07612367003896 | Tubing holder left side | Medela AG | 2024-05-31 |
| 07612367003742 | Safety Set for railholder | Medela AG | 2024-05-31 |
| 07612367003735 | Reusable serial connector | Medela AG | 2024-05-31 |
| 07612367003698 | Overflow protection device | Medela AG | 2024-05-31 |
| 07612367003575 | Change over valve | Medela AG | 2024-05-31 |
| 07612367003568 | Quiver 480mm | Medela AG | 2024-05-31 |
| 07612367003551 | Quiver 280mm | Medela AG | 2024-05-31 |
| 07612367003681 | Clip for Lid | Medela AG | 2021-08-12 |
| 07612367003582 | Disposable Specimen Cup | Medela AG | 2016-12-05 |
| 07612367002820 | Small lid with conical patient connection and overflow protection device | Medela AG | 2016-10-24 |
| 07612367002677 | Suction jar polysulfone 0.25l | Medela AG | 2016-10-24 |
| 07612367002684 | Suction jar polysulfone, 0.5l | Medela AG | 2016-10-24 |
| 07612367002691 | Suction Jar Polysulfone, 1l | Medela AG | 2016-10-24 |
| 07612367002707 | Suction jar polysulfone 2l | Medela AG | 2016-10-24 |
| 07612367002714 | Suction jar polysulfone 3l | Medela AG | 2016-10-24 |
| 07612367002721 | Suction jar polysulfone 5l | Medela AG | 2016-10-24 |
| 07612367002806 | Large lid with conical patient connection 6–10 mm | Medela AG | 2016-10-24 |
| 07612367002813 | Large lid with conical patient connection 10–14 mm | Medela AG | 2016-10-24 |
| 07612367002837 | Lid for safety Set with overflow protection device | Medela AG | 2016-10-24 |
| 07612367003933 | Foot vacuum regulator | Medela AG | 2016-10-03 |
| 07612367003957 | Disposable overflow protection / bacteria filter | Medela AG | 2016-10-03 |
| 07612367004138 | Safety device plugged into pump | Medela AG | 2016-10-03 |
| 07612367004152 | Disposable overflow protection / bacteria filter | Medela AG | 2016-10-03 |
| 07612367004169 | Disposable bacteria filter | Medela AG | 2016-10-03 |
| 07612367004183 | Disposable bacteria / odour filter | Medela AG | 2016-10-03 |
| 07612367004237 | Silicone tubing | Medela AG | 2016-10-03 |
| 07612367003599 | Change-over valve with clampholder and tubing set | Medela AG | 2016-09-24 |