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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: QPB FDA class 2

    System, Suction, Lipoplasty For Removal

    General, Plastic Surgery

    View full classification →

    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.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    AYON Body Contouring System (AYON SYSTEM)
    PAL 7020 Console
    PAL Aspiration System
    AirSculpt Body Contouring System (AIRS-1-SYS)
    Vitruvian Liposaber
    Liposaver
    PAL Infiltration System
    PAL System
    PAL Single-Use Cannulas
    Dermapose Access
    PowerX Lipo System
    VASERlipo System
    PAL Multi-Use Cannulas and PAL Manual Wand
    VITRUVIAN INFILTRATION PUMP
    Basic, Dominant Flex
    VITRUVIAN ULTIMATE ASPIRATOR
    Basic, Dominant Flex, KV-6
    SUCTION LIPOPLASTY ACCESSORIES
    HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4MM DIA, 26 CM LENGTH, 3 APERTURE REUSABLE CANNULA, 4MM DIA,
    MICROAIRE SURGICAL INSTRUMENTS LLC
    SUCTION LIPOLASTY ACCESSORIES
    SOUND SURGICAL VASER 2.1 LIPO SYSTEM
    SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM
    EUROMI EVA SP6
    PHASER LIPOPLASTY SYSTEM (DUR-01), PHASER DISPOSABLE KIT (DIS-01), PHASER WASTE COLLECTION KIT (WAS-01), PHASER CANNULAE
    LIPOSE DISPOSABLE CANNULA
    BODY-JET
    POWER ASPIRATOR, MODEL LS2 OR LS2DP
    LIPO CANNULA
    LIPOSAT BASIC (INFILTRATION PUMP), MODEL 92-007 688
    MEDELA DOMINANT 50 LIPO, MODEL 600-5706
    CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT
    LIPOSAT (INFILTRATION PUMP), MODEL 00 002 274; VACUSAT (SUCTION UNIT), MODEL 00 002 252 (220 V), 00 002 318 (110 V);
    TULIP DISPOSABLE CANNULAS
    SORING GMBH SONOCA LIPO
    MACROPORE PURICEL LIPOPLASTY SYSTEM
    MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS
    HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III
    AIRBRUSH LIPOSCULPTOR SYSTEM
    SOUNDVASER SYSTEM
    STARS2000 POWER CANNULA
    MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED)
    KINETIC CANNULA
    LIPOMATIC; LIPOMATIC LIPOSUCTION DEVICE
    XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNULAE
    ACCELERATOR RECIPROCATING CANNULA
    XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT
    MICRO-FRANCE LIPOSUCTION CANNULAS
    RICHTER LIPOPLASTY CANNULAS AND ACCESSORIES
    LIGHT DUTY PNEUMATIC INSTRUMENT MODEL NUMBER PAD-100, HEAVY DUTY PNEUMATIC INSTRUMENT MODEL PAD-200, LIGHT DUTY ELECTRI

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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