BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    PURE Laser

    Reg #: 3019252665 · FEI: 3019252665 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GEVASOL TECHNOLOGIES
    Registration Number
    3019252665
    FEI Number
    3019252665
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    11 Hasadna St, North Industrial Zone
    City
    Beit Shean Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K222369

    Owner / Operator

    Firm Name
    GevaSol Technologies
    Operator Number
    10087493
    Address
    11 Hasadna St, North Industrial Zone
    City
    Beit Shean
    State
    Northern
    Postal Code
    1173838
    Country
    IL
    Correspondent
    Yoram Levy

    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
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    PURE Laser Powered Laser Surgical Instrument – PURE Laser EPL810 With EPL810 HP

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)