BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Glo2Facial by Geneo RF PRO Handpiece Kit for GENEO X

    Reg #: 3008753275 · FEI: 3008753275 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    POLLOGEN LTD
    Registration Number
    3008753275
    FEI Number
    3008753275
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6 Kaufman Street (main)
    City
    Tel Aviv
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K233766

    Owner / Operator

    Firm Name
    Pollogen
    Operator Number
    10038980
    Address
    6 Kaufman Str.
    City
    Tel Aviv
    State
    IL-TA
    Postal Code
    6801298
    Country
    IL
    Correspondent
    Moshe Strass

    US Agent

    Business Name
    Qsite
    Contact Name
    Tova Rivnay
    Address
    77 Dorcar Rd
    City
    Newton
    State
    MA
    ZIP
    02459
    Country
    US
    Email
    [email protected]
    Phone
    512 5354930

    Products

    Device Name Product Code
    Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction PAY
    Massager, Therapeutic, Electric ISA

    Proprietary Names

    Glo2Facial by Geneo RF PRO Handpiece Kit for GENEO X GENEO X U PACKED with GENEO X TRIPOLLAR KIT USA PACKED GENEO X ELITE System with TriPollar RF and Oxygeneo Applicators RF PRO Handpiece for GENEO X GENEO X U with TRIPOLLAR RF APPLICATOR KIT for GENEO X U

    Establishment Types

    Manufacture Medical Device