BEUDAMED
    Product Code: QPB FDA class 2 21 CFR 878.5040

    System, Suction, Lipoplasty For Removal

    General, Plastic Surgery

    The System for Suction Lipoplasty for Removal is a suction lipoplasty system intended for the removal of adipose tissue for purposes of aesthetic body contouring, used in cosmetic surgical procedures. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 878.5040 in the General and Plastic Surgery specialty. It carries product code QPB and is not an implant and not life-sustaining.

    View on FDA
    510(k)s
    58
    FEI Numbers
    48
    Registration Numbers
    48
    Unique Applicants
    38
    Years Active
    28

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    Basic Information

    Product Code
    QPB
    Device Class
    FDA class 2
    Regulation Number
    878.5040
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 58 510(k) clearances via K numbers.

    K Number Device Name
    K251944 Lipocosm Harmonic System
    K253396 AYON Body Contouring System™ (AYON SYSTEM)
    K252495 LSSA (NP-200)
    K244050 AYON Body Contouring System (AYON SYSTEM)
    K244026 PAL 7020 Console
    K242804 PAL Aspiration System
    K241835 AirSculpt Body Contouring System (AIRS-1-SYS)
    K240188 Vitruvian Liposaber
    K212969 Liposaver
    K220318 PAL Infiltration System
    K212024 PAL System
    K192694 PAL Single-Use Cannulas
    K200168 Dermapose Access
    K190555 PowerX Lipo System
    K190551 VASERlipo System
    K171286 PAL Multi-Use Cannulas and PAL Manual Wand
    K170629 VITRUVIAN INFILTRATION PUMP
    K170329 Basic, Dominant Flex
    K161722 VITRUVIAN ULTIMATE ASPIRATOR
    K150134 Basic, Dominant Flex, KV-6
    K132353 SUCTION LIPOPLASTY ACCESSORIES
    K121218 HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE REUSABLE CANNULA, 4MM DIA,
    K113128 MICROAIRE SURGICAL INSTRUMENTS LLC
    K113795 SUCTION LIPOLASTY ACCESSORIES
    K110306 SOUND SURGICAL VASER 2.1 LIPO SYSTEM
    K110255 SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM
    K101413 EUROMI EVA SP6
    K092066 PHASER LIPOPLASTY SYSTEM (DUR-01), PHASER DISPOSABLE KIT (DIS-01), PHASER WASTE COLLECTION KIT (WAS-01), PHASER CANNULAE
    K093067 LIPOSE DISPOSABLE CANNULA
    K082025 BODY-JET
    K081593 POWER ASPIRATOR, MODEL LS2 OR LS2DP
    K081039 LIPO CANNULA
    K072793 LIPOSAT BASIC (INFILTRATION PUMP), MODEL 92-007 688
    K063336 MEDELA DOMINANT 50 LIPO, MODEL 600-5706
    K063235 CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT
    K053451 LIPOSAT (INFILTRATION PUMP), MODEL 00 002 274; VACUSAT (SUCTION UNIT), MODEL 00 002 252 (220 V), 00 002 318 (110 V);
    K060089 TULIP DISPOSABLE CANNULAS
    K052183 SORING GMBH SONOCA LIPO
    K042261 MACROPORE PURICEL LIPOPLASTY SYSTEM
    K041058 MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS
    K032802 HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III
    K031881 AIRBRUSH LIPOSCULPTOR SYSTEM
    K022051 SOUNDVASER SYSTEM
    K012236 STARS2000 POWER CANNULA
    K004005 MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED)
    K012042 KINETIC CANNULA
    K010311 LIPOMATIC; LIPOMATIC LIPOSUCTION DEVICE
    K010666 XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE
    K001803 ACCELERATOR RECIPROCATING CANNULA
    K992855 XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT
    K992282 MICRO-FRANCE LIPOSUCTION CANNULAS
    K990602 RICHTER LIPOPLASTY CANNULAS AND ACCESSORIES
    K981922 LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY DUTY PNEUMATIC INSTRUMENT MODEL PAD-200, LIGHT DUTY ELECTRI
    K980771 LYSONIX SUCTION LIPOPLASTY SYSTEM
    K981527 MENTOR PATHWAY INTRODUCER/DILATOR
    K981215 PSI-TEC LIPOSUCTION ASPIRATOR
    K981172 LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES
    K980763 LYSONIX LIPOPLASTY ACCESS PORT

    FEI Numbers

    This FDA classification entry is associated with 48 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 48 registration numbers. Click on an entry to view related FDA registrations.