BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Universal IPL treatment Head

    Reg #: 3009040934 · FEI: 3009040934 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ATENA (FROM THE IMCO GROUP) LTD
    Registration Number
    3009040934
    FEI Number
    3009040934
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    HaTa'asiya 9
    City
    Nesher Haifa
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K193500

    Owner / Operator

    Firm Name
    ATENA (FROM THE IMCO GROUP) LTD
    Operator Number
    10091388
    Address
    HaTa'asiya 9
    City
    Nesher
    State
    Haifa
    Postal Code
    3688808
    Country
    IL
    Correspondent
    Roei Oring

    Products

    Device Name Product Code
    Powered Light Based Non-Laser Surgical Instrument With Thermal Effect ONF
    Powered Laser Surgical Instrument GEX
    Powered Laser Surgical Instrument With MicrobeamFractional Output ONG

    Proprietary Names

    Universal IPL treatment Head M22 Universal IPL treatment head Stellar M22 IPL HP

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)