BEUDAMED
    Product Code: OUP FDA class 2 21 CFR 878.4790

    Powered Surgical Instrument For Improvement In The Appearance Of Cellulite

    General, Plastic Surgery

    The Powered Surgical Instrument for Improvement in the Appearance of Cellulite (product code OUP) is a minimally invasive surgical device used for controlled release of subcutaneous tissue bands to improve the appearance of cellulite. It employs powered mechanical action to precisely cut fibrous septa beneath the skin. As an FDA Class 2 device under regulation 878.4790, it requires 510(k) premarket clearance and falls within the General and Plastic Surgery specialty. The device is not an implant and is not life-sustaining.

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    510(k)s
    9
    FEI Numbers
    14
    Registration Numbers
    14
    Unique Applicants
    5
    Years Active
    10

    Basic Information

    Product Code
    OUP
    Device Class
    FDA class 2
    Regulation Number
    878.4790
    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

    Used for controlled release of subcutaneous tissue for improvement in the appearance of cellulite.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 9 510(k) clearances via K numbers.

    K Number Device Name
    K232153 Avéli
    K221336 Avéli
    K212399 Aveli
    K192185 The Cellfina System
    K161885 The Cellfina System
    K153677 The Cellfina System
    K150505 Cellfina System
    K134010 CABOCHON SYSTEM
    DEN110004 CABOCHON SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.