BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    FORMATK SYSTEMS LTD.

    Reg #: 3011670002 · FEI: 3011670002 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    FORMATK SYSTEMS LTD.
    Registration Number
    3011670002
    FEI Number
    3011670002
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3 Hayozma St.
    City
    Tirat Hacarmel Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K162781

    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 Laser Surgical Instrument GEX
    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

    MAGMA SPARK DioBreeze LLD HR-Max ALD HR-Mini Alpha Magma Spark Pro Magma Spark Plus Forma System, Forma Light System iProElite System Magma System SheerWave Plus, IPLaser 360

    Establishment Types

    Manufacture Medical Device