BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Forma System, Forma Light System

    Reg #: 3011670002 · FEI: 3011670002 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    FORMATK SYSTEMS LTD.
    Registration Number
    3011670002
    FEI Number
    3011670002
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3 Hayozma St.
    City
    Tirat Hacarmel Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K160195

    Owner / Operator

    Firm Name
    Formatk Systems, Ltd.
    Operator Number
    10051579
    Address
    3 Hayozma St.
    City
    Tirat Carmel, North District
    State
    IL-NOTA
    Postal Code
    3903203
    Country
    IL

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Powered Light Based Non-Laser Surgical Instrument With Thermal Effect ONF
    Massager, Vacuum, Radio Frequency Induced Heat PBX
    Lamp, Infrared, Therapeutic Heating ILY
    Brush, Dermabrasion, Powered GFE

    Proprietary Names

    Forma System, Forma Light System iProElite System

    Establishment Types

    Manufacture Medical Device