FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K121218 |
ANDREW TECHNOLOGIES, LLC |
HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE REUSABLE CANNULA, 4MM DIA, |
12/13/2012 |
K092066 |
ANDREW TECHNOLOGIES, LLC |
PHASER LIPOPLASTY SYSTEM (DUR-01), PHASER DISPOSABLE KIT (DIS-01), PHASER WASTE COLLECTION KIT (WAS-01), PHASER CANNULAE |
04/12/2010 |
K031881 |
BIOSCULPTURE TECHNOLOGY, INC. |
AIRBRUSH LIPOSCULPTOR SYSTEM |
07/28/2003 |
K170629 |
Black & Black Surgical, Inc. |
VITRUVIAN INFILTRATION PUMP |
06/22/2017 |
K161722 |
BLACK & BLACK SURGICAL, INC. |
VITRUVIAN ULTIMATE ASPIRATOR |
07/26/2016 |
K001803 |
BYRON MEDICAL |
ACCELERATOR RECIPROCATING CANNULA |
08/04/2000 |
K981172 |
BYRON MEDICAL |
LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES |
06/30/1998 |
K981215 |
BYRON MEDICAL |
PSI-TEC LIPOSUCTION ASPIRATOR |
07/01/1998 |
K060089 |
CELL BIO-SYSTEMS, INC. |
TULIP DISPOSABLE CANNULAS |
04/27/2006 |
K063235 |
CYTORI THERAPEUTICS, INC. |
CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT |
01/24/2007 |
K101413 |
EUROMI SA |
EUROMI EVA SP6 |
12/16/2010 |
K010311 |
EUROMI SA |
LIPOMATIC; LIPOMATIC LIPOSUCTION DEVICE |
06/29/2001 |
K032802 |
HK SURGICAL, INC. |
HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III |
11/19/2003 |
K082025 |
HUMAN MED AG |
BODY-JET |
08/13/2008 |
K132353 |
INEX |
SUCTION LIPOPLASTY ACCESSORIES |
07/30/2014 |
K012236 |
KMI KOLSTER METHODS, INC. |
STARS2000 POWER CANNULA |
11/19/2001 |
K093067 |
LIPOSE CORP. |
LIPOSE DISPOSABLE CANNULA |
12/29/2009 |
K980763 |
LYSONIX, INC. |
LYSONIX LIPOPLASTY ACCESS PORT |
05/28/1998 |
K980771 |
LYSONIX, INC. |
LYSONIX SUCTION LIPOPLASTY SYSTEM |
07/13/1998 |
K042261 |
MACROPORE BIOSURGERY, INC. |
MACROPORE PURICEL LIPOPLASTY SYSTEM |
09/20/2004 |
K150134 |
MEDELA AG |
Basic, Dominant Flex, KV-6 |
04/21/2015 |
K063336 |
MEDELA AG |
MEDELA DOMINANT 50 LIPO, MODEL 600-5706 |
02/26/2007 |
K081593 |
MEDICAL DEVICE RESOURCE CORP. |
POWER ASPIRATOR, MODEL LS2 OR LS2DP |
07/23/2008 |
K010666 |
MEDTRONIC XOMED, INC. |
XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE |
05/07/2001 |
K981527 |
MENTOR CORP. |
MENTOR PATHWAY INTRODUCER/DILATOR |
07/09/1998 |
K004005 |
MENTOR CORP. |
MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED) |
10/12/2001 |
K192694 |
MicroAire Surgical Instruments |
PAL Single-Use Cannulas |
05/14/2020 |
K981922 |
MICROAIRE SURGICAL INSTRUMENTS, INC. |
LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY DUTY PNEUMATIC INSTRUMENT MODEL PAD-200, LIGHT DUTY ELECTRI |
12/10/1998 |
K113128 |
MICROAIRE SURGICAL INSTRUMENTS, LLC |
MICROAIRE SURGICAL INSTRUMENTS LLC |
08/17/2012 |
K220318 |
MicroAire Surgical Instruments, LLC |
PAL Infiltration System |
10/14/2022 |
K171286 |
MicroAire Surgical Instruments, LLC |
PAL Multi-Use Cannulas and PAL Manual Wand |
10/13/2017 |
K212024 |
MicroAire Surgical Instruments, LLC |
PAL System |
06/10/2022 |
K081039 |
MILLENNIUM MEDICAL TECHNOLOGIES, INC. |
LIPO CANNULA |
07/10/2008 |
K041058 |
MISONIX, INC. |
MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS |
05/17/2004 |
K170329 |
Modela AG |
Basic, Dominant Flex |
03/24/2017 |
K053451 |
MOELLER MEDICAL GMBH & CO. KG |
LIPOSAT (INFILTRATION PUMP), MODEL 00 002 274; VACUSAT (SUCTION UNIT), MODEL 00 002 252 (220 V), 00 002 318 (110 V); |
08/25/2006 |
K072793 |
MOELLER MEDICAL GMBH & CO. KG |
LIPOSAT BASIC (INFILTRATION PUMP), MODEL 92-007 688 |
03/04/2008 |
K113795 |
NORMAN M. BLACK III |
SUCTION LIPOLASTY ACCESSORIES |
08/07/2012 |
K200168 |
Puregraft LLC |
Dermapose Access |
04/22/2020 |
K012042 |
RELIANCE MEDICAL CORP. |
KINETIC CANNULA |
09/20/2001 |
K190555 |
Solta Medical |
PowerX Lipo System |
05/01/2019 |
K190551 |
Solta Medical |
VASERlipo System |
05/01/2019 |
K052183 |
SORING GMBH MEDIZINTECHNIK |
SORING GMBH SONOCA LIPO |
10/07/2005 |
K110255 |
SOUND SURGICAL TECHNOLOGIES LLC. |
SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM |
04/04/2011 |
K110306 |
SOUND SURGICAL TECHNOLOGIES LLC. |
SOUND SURGICAL VASER 2.1 LIPO SYSTEM |
06/23/2011 |
K022051 |
SOUND SURGICAL TECHNOLOGIES LLC. |
SOUNDVASER SYSTEM |
09/11/2002 |
K990602 |
TECSA TECHNICAL SERVICES |
RICHTER LIPOPLASTY CANNULAS AND ACCESSORIES |
07/01/1999 |
K992282 |
XOMED, INC. |
MICRO-FRANCE LIPOSUCTION CANNULAS |
09/23/1999 |
K992855 |
XOMED, INC. |
XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT |
01/21/2000 |