BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    neoV1470

    Reg #: 3011514163 · FEI: 3011514163 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    G.N.S NEOLASER LTD.
    Registration Number
    3011514163
    FEI Number
    3011514163
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7 HaEshel St PO BOX 3203
    City
    Caesarea Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K133006

    Owner / Operator

    Firm Name
    G.N.S neoLaser Ltd.
    Operator Number
    10048512
    Address
    7 Ha'Eshel St PO BOX 3203
    City
    Caesarea
    State
    Central
    Postal Code
    38900
    Country
    IL
    Correspondent
    Gil Shapira

    US Agent

    Business Name
    CEO Adler MicroMed
    Contact Name
    Brian Chandler
    Address
    6842 Elaine Way
    City
    San Diego
    State
    CA
    ZIP
    92120
    Country
    US
    Email
    [email protected]
    Phone
    484 9957919

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    neoV1470 neoV980 neoV1064 neoV810

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device