BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    POLLOGEN LEGEND

    DI: 07290016586046 · Model: POLLOGEN LEGEND+ · POLLOGEN LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    POLLOGEN LEGEND
    Primary DI
    07290016586046
    Version / Model
    POLLOGEN LEGEND+
    Catalog Number
    21400800U
    Company Name
    POLLOGEN LTD
    Labeler DUNS
    514905681
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-04-06
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    dd4eb0db-9895-45f2-8a53-32b4ea7ec9c7

    Device Description

    The Pollogen Legend+ VO hand piece is designed to deliver radiofrequency energy to the skin in a non-homogeneous fractional manner, via an array of multi-electrode pins. The array delivers bipolar RF energy to the skin, resulting in heating of skin directly below the electrodes, to temperatures leading to ablation and resurfacing of the skin.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    Yes
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    GMDN Terms

    Code Name
    58454 Radio-frequency skin surface treatment system

    Identifiers

    Type ID
    Primary 07290016586046