System, Suction, Lipoplasty For Removal

FDA product code QPB · 58 cleared devices

Class 2 General, Plastic Surgery

Regulation: 21 CFR 878.5040
Review panel: SU
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1998-05-28 – 2026-09-05

A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring

QPB 2026-09-05

LipoSurg ARTIST

Applicant NOUVAG AG

K number K254135

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QPB 2026-08-21

AYON™ Power Liposuction Cannulas and AYON™ Power Liposuction Cannula Adaptors

Applicant Apyx Medical Corporation

K number K261710

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QPB 2026-06-08

Lipocosm Harmonic System

Applicant Lipocosm, LLC

K number K251944

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QPB 2026-05-08

AYON Body Contouring System™ (AYON SYSTEM)

Applicant Apyx Medical Corporation

K number K253396

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QPB 2026-04-03

LSSA (NP-200)

Applicant Newpong Co., Ltd.

K number K252495

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QPB 2025-05-12

AYON Body Contouring System (AYON SYSTEM)

Applicant Apyx Medical Corporation

K number K244050

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QPB 2025-04-25

PAL 7020 Console

Applicant Microaire Surgical Instruments, LLC

K number K244026

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QPB 2024-12-30

PAL Aspiration System

Applicant Microaire Surgical Instruments, LLC

K number K242804

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QPB 2024-11-27

AirSculpt Body Contouring System (AIRS-1-SYS)

Applicant Cellmyx

K number K241835

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QPB 2024-09-13

Vitruvian Liposaber

Applicant Black & Black Surgical, Inc.

K number K240188

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QPB 2024-08-07

Liposaver

Applicant Lhbiomed Co., Ltd.

K number K212969

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QPB 2022-10-14

PAL Infiltration System

Applicant Microaire Surgical Instruments, LLC

K number K220318

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QPB 2022-06-10

PAL System

Applicant Microaire Surgical Instruments, LLC

K number K212024

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QPB 2020-05-14

PAL Single-Use Cannulas

Applicant Microaire Surgical Instruments

K number K192694

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QPB 2020-04-22

Dermapose Access

Applicant Puregraft, LLC

K number K200168

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QPB 2019-05-01

PowerX Lipo System

Applicant Solta Medical

K number K190555

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QPB 2019-05-01

VASERlipo System

Applicant Solta Medical

K number K190551

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QPB 2017-10-13

PAL Multi-Use Cannulas and PAL Manual Wand

Applicant Microaire Surgical Instruments, LLC

K number K171286

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QPB 2017-06-22

VITRUVIAN INFILTRATION PUMP

Applicant Black & Black Surgical, Inc.

K number K170629

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QPB 2017-03-24

Basic, Dominant Flex

Applicant Modela AG

K number K170329

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QPB 2016-07-26

VITRUVIAN ULTIMATE ASPIRATOR

Applicant Black & Black Surgical, Inc.

K number K161722

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QPB 2012-12-13

HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE REUSABLE CANNULA, 4MM DIA,

Applicant Andrew Technologies, LLC

K number K121218

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QPB 2012-08-17

MICROAIRE SURGICAL INSTRUMENTS LLC

Applicant Microaire Surgical Instruments, LLC

K number K113128

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QPB 2012-08-07

SUCTION LIPOLASTY ACCESSORIES

Applicant Norman M. Black Iii

K number K113795

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QPB 2011-06-23

SOUND SURGICAL VASER 2.1 LIPO SYSTEM

Applicant Sound Surgical Technologies, LLC

K number K110306

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QPB 2011-04-04

SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM

Applicant Sound Surgical Technologies, LLC

K number K110255

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QPB 2010-12-16

EUROMI EVA SP6

Applicant Euromi S.A

K number K101413

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QPB 2010-04-12

PHASER LIPOPLASTY SYSTEM (DUR-01), PHASER DISPOSABLE KIT (DIS-01), PHASER WASTE COLLECTION KIT (WAS-01), PHASER CANNULAE

Applicant Andrew Technologies, LLC

K number K092066

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QPB 2009-12-29

LIPOSE DISPOSABLE CANNULA

Applicant Lipose Corp.

K number K093067

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QPB 2008-08-13

BODY-JET

Applicant Human Med AG

K number K082025

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QPB 2008-07-23

POWER ASPIRATOR, MODEL LS2 OR LS2DP

Applicant Medical Device Resource Corp.

K number K081593

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QPB 2008-07-10

LIPO CANNULA

Applicant Millennium Medical Technologies, Inc.

K number K081039

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QPB 2008-03-04

LIPOSAT BASIC (INFILTRATION PUMP), MODEL 92-007 688

Applicant Moeller Medical GmbH & Co. KG

K number K072793

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QPB 2007-02-26

MEDELA DOMINANT 50 LIPO, MODEL 600-5706

Applicant Medela AG

K number K063336

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QPB 2007-01-24

CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT

Applicant Cytori Therapeutics, Inc.

K number K063235

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QPB 2006-08-25

LIPOSAT (INFILTRATION PUMP), MODEL 00 002 274; VACUSAT (SUCTION UNIT), MODEL 00 002 252 (220 V), 00 002 318 (110 V);

Applicant Moeller Medical GmbH & Co. KG

K number K053451

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QPB 2006-04-27

TULIP DISPOSABLE CANNULAS

Applicant Cell Bio-Systems, Inc.

K number K060089

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QPB 2005-10-07

SORING GMBH SONOCA LIPO

Applicant Soring GmbH Medizintechnik

K number K052183

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QPB 2004-09-20

MACROPORE PURICEL LIPOPLASTY SYSTEM

Applicant Macropore Biosurgery, Inc.

K number K042261

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QPB 2004-05-17

MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS

Applicant Misonix, Inc.

K number K041058

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QPB 2003-11-19

HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III

Applicant Hk Surgical, Inc.

K number K032802

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QPB 2003-07-28

AIRBRUSH LIPOSCULPTOR SYSTEM

Applicant Biosculpture Technology, Inc.

K number K031881

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QPB 2002-09-11

SOUNDVASER SYSTEM

Applicant Sound Surgical Technologies, LLC

K number K022051

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QPB 2001-11-19

STARS2000 POWER CANNULA

Applicant Kmi Kolster Methods, Inc.

K number K012236

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QPB 2001-10-12

MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED)

Applicant Mentor Corp.

K number K004005

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QPB 2001-09-20

KINETIC CANNULA

Applicant Reliance Medical Corp.

K number K012042

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QPB 2001-06-29

LIPOMATIC; LIPOMATIC LIPOSUCTION DEVICE

Applicant Euromi S.A

K number K010311

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QPB 2001-05-07

XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE

Applicant Medtronic Xomed, Inc.

K number K010666

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QPB 2000-08-04

ACCELERATOR RECIPROCATING CANNULA

Applicant Byron Medical

K number K001803

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QPB 2000-01-21

XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT

Applicant Xomed, Inc.

K number K992855

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QPB 1999-09-23

MICRO-FRANCE LIPOSUCTION CANNULAS

Applicant Xomed, Inc.

K number K992282

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QPB 1999-07-01

RICHTER LIPOPLASTY CANNULAS AND ACCESSORIES

Applicant Tecsa Technical Services

K number K990602

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QPB 1998-12-10

LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY DUTY PNEUMATIC INSTRUMENT MODEL PAD-200, LIGHT DUTY ELECTRI

Applicant Microaire Surgical Instruments, Inc.

K number K981922

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QPB 1998-07-13

LYSONIX SUCTION LIPOPLASTY SYSTEM

Applicant Lysonix, Inc.

K number K980771

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QPB 1998-07-09

MENTOR PATHWAY INTRODUCER/DILATOR

Applicant Mentor Corp.

K number K981527

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QPB 1998-07-01

PSI-TEC LIPOSUCTION ASPIRATOR

Applicant Byron Medical

K number K981215

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QPB 1998-06-30

LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES

Applicant Byron Medical

K number K981172

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QPB 1998-05-28

LYSONIX LIPOPLASTY ACCESS PORT

Applicant Lysonix, Inc.

K number K980763

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