BEUDAMED
    Product Code: PKT FDA class 2 21 CFR 878.5400

    Laser For Disruption Of Adipocyte Cells For Aesthetic Use

    General, Plastic Surgery

    The Laser For Disruption Of Adipocyte Cells For Aesthetic Use (product code PKT) is a Class 2 general and plastic surgery device that uses laser energy to disrupt adipocyte cells for body contouring or reduction in circumference of body areas, regulated under 878.5400. It requires 510(k) clearance and is GMP exempt. The device is not flagged as an implant or life-sustaining product.

    View on FDA
    510(k)s
    19
    FEI Numbers
    16
    Registration Numbers
    16
    Unique Applicants
    13
    Years Active
    9

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    Basic Information

    Product Code
    PKT
    Device Class
    FDA class 2
    Regulation Number
    878.5400
    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

    Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 19 510(k) clearances via K numbers.

    K Number Device Name
    K240658 1060nm laser body slimming machine
    K233962 ReBorn (1050nm)
    K231971 DEKA PHYSIQ 360
    K231131 Diode Laser Body Sculpture Systems
    K222226 EON
    K222265 Diosculpt
    K211681 EON
    K212331 BodySculp
    K211402 Powersculp laser lipolysis system
    K192970 SLIMUS
    K201731 Diode Laser Body Sculpture System
    K191068 Powersculp laser lipolysis system
    K180511 Eon FR
    K182741 SculpSure
    K171992 SculpSure
    K171111 Sculpsure
    K160470 SculpSure
    K150724 SculpSure
    K150230 SculpSure

    FEI Numbers

    This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.