Atlas FDA

QPB

58 FDA 510(k) clearances · Product code

112 daysmedian time to decision
290 days90th percentile
58clearances measured

FDA profile

Official device name
System, Suction, Lipoplasty For Removal
Device class
Class II (moderate risk)
Regulation
21 CFR 878.5040
Medical specialty
General, Plastic Surgery
FDA definition
A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring
Adverse events (MAUDE)
2023: 28
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Lipocosm Harmonic System (K251944)Lipocosm, LLC2026-06-08
AYON Body Contouring Systemâ„¢ (AYON SYSTEM) (K253396)Apyx Medical Corporation2026-05-08
LSSA (NP-200) (K252495)Newpong Co., Ltd.2026-04-03
AYON Body Contouring System (AYON SYSTEM) (K244050)Apyx Medical Corporation2025-05-12
PAL 7020 Console (K244026)Microaire Surgical Instruments, LLC2025-04-25
PAL Aspiration System (K242804)Microaire Surgical Instruments, LLC2024-12-30
AirSculpt Body Contouring System (AIRS-1-SYS) (K241835)Cellmyx2024-11-27
Vitruvian Liposaber (K240188)Black & Black Surgical, Inc.2024-09-13
Liposaver (K212969)Lhbiomed Co., Ltd.2024-08-07
PAL Infiltration System (K220318)Microaire Surgical Instruments, LLC2022-10-14
PAL System (K212024)Microaire Surgical Instruments, LLC2022-06-10
PAL Single-Use Cannulas (K192694)Microaire Surgical Instruments2020-05-14
Dermapose Access (K200168)Puregraft, LLC2020-04-22
PowerX Lipo System (K190555)Solta Medical2019-05-01
VASERlipo System (K190551)Solta Medical2019-05-01
PAL Multi-Use Cannulas and PAL Manual Wand (K171286)Microaire Surgical Instruments, LLC2017-10-13
VITRUVIAN INFILTRATION PUMP (K170629)Black & Black Surgical, Inc.2017-06-22
Basic, Dominant Flex (K170329)Modela AG2017-03-24
VITRUVIAN ULTIMATE ASPIRATOR (K161722)Black & Black Surgical, Inc.2016-07-26
Basic, Dominant Flex, KV-6 (K150134)Medela AG2015-04-21
SUCTION LIPOPLASTY ACCESSORIES (K132353)Inex2014-07-30
HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE REUSABLE CANNULA, 4MM DIA, (K121218)Andrew Technologies, LLC2012-12-13
MICROAIRE SURGICAL INSTRUMENTS LLC (K113128)Microaire Surgical Instruments, LLC2012-08-17
SUCTION LIPOLASTY ACCESSORIES (K113795)Norman M. Black Iii2012-08-07
SOUND SURGICAL VASER 2.1 LIPO SYSTEM (K110306)Sound Surgical Technologies, LLC2011-06-23
SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM (K110255)Sound Surgical Technologies, LLC2011-04-04
EUROMI EVA SP6 (K101413)Euromi S.A2010-12-16
PHASER LIPOPLASTY SYSTEM (DUR-01), PHASER DISPOSABLE KIT (DIS-01), PHASER WASTE COLLECTION KIT (WAS-01), PHASER CANNULAE (K092066)Andrew Technologies, LLC2010-04-12
LIPOSE DISPOSABLE CANNULA (K093067)Lipose Corp.2009-12-29
BODY-JET (K082025)Human Med AG2008-08-13
POWER ASPIRATOR, MODEL LS2 OR LS2DP (K081593)Medical Device Resource Corp.2008-07-23
LIPO CANNULA (K081039)Millennium Medical Technologies, Inc.2008-07-10
LIPOSAT BASIC (INFILTRATION PUMP), MODEL 92-007 688 (K072793)Moeller Medical GmbH & Co. KG2008-03-04
MEDELA DOMINANT 50 LIPO, MODEL 600-5706 (K063336)Medela AG2007-02-26
CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT (K063235)Cytori Therapeutics, Inc.2007-01-24
LIPOSAT (INFILTRATION PUMP), MODEL 00 002 274; VACUSAT (SUCTION UNIT), MODEL 00 002 252 (220 V), 00 002 318 (110 V); (K053451)Moeller Medical GmbH & Co. KG2006-08-25
TULIP DISPOSABLE CANNULAS (K060089)Cell Bio-Systems, Inc.2006-04-27
SORING GMBH SONOCA LIPO (K052183)Soring GmbH Medizintechnik2005-10-07
MACROPORE PURICEL LIPOPLASTY SYSTEM (K042261)Macropore Biosurgery, Inc.2004-09-20
MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS (K041058)Misonix, Inc.2004-05-17
HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III (K032802)Hk Surgical, Inc.2003-11-19
AIRBRUSH LIPOSCULPTOR SYSTEM (K031881)Biosculpture Technology, Inc.2003-07-28
SOUNDVASER SYSTEM (K022051)Sound Surgical Technologies, LLC2002-09-11
STARS2000 POWER CANNULA (K012236)Kmi Kolster Methods, Inc.2001-11-19
MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED) (K004005)Mentor Corp.2001-10-12
KINETIC CANNULA (K012042)Reliance Medical Corp.2001-09-20
LIPOMATIC; LIPOMATIC LIPOSUCTION DEVICE (K010311)Euromi S.A2001-06-29
XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE (K010666)Medtronic Xomed, Inc.2001-05-07
ACCELERATOR RECIPROCATING CANNULA (K001803)Byron Medical2000-08-04
XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT (K992855)Xomed, Inc.2000-01-21
MICRO-FRANCE LIPOSUCTION CANNULAS (K992282)Xomed, Inc.1999-09-23
RICHTER LIPOPLASTY CANNULAS AND ACCESSORIES (K990602)Tecsa Technical Services1999-07-01
LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY DUTY PNEUMATIC INSTRUMENT MODEL PAD-200, LIGHT DUTY ELECTRI (K981922)Microaire Surgical Instruments, Inc.1998-12-10
LYSONIX SUCTION LIPOPLASTY SYSTEM (K980771)Lysonix, Inc.1998-07-13
MENTOR PATHWAY INTRODUCER/DILATOR (K981527)Mentor Corp.1998-07-09
PSI-TEC LIPOSUCTION ASPIRATOR (K981215)Byron Medical1998-07-01
LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES (K981172)Byron Medical1998-06-30
LYSONIX LIPOPLASTY ACCESS PORT (K980763)Lysonix, Inc.1998-05-28

Track QPB automatically

Every clearance here is in the API, with alerts when new ones post.