BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    FelxGuard

    Reg #: 3003168101 · FEI: 3003168101 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    LISA LASER PRODUCTS GMBH
    Registration Number
    3003168101
    FEI Number
    3003168101
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ALBERT-EINSTEIN-STR. 4
    City
    KATLENBURG-LINDAU Lower Saxony
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K070924

    Owner / Operator

    Firm Name
    OMNIGUIDE, INC.
    Operator Number
    9070939
    Address
    43 Manning Rd
    City
    Billerica
    State
    MA
    Postal Code
    01821
    Country
    US
    Correspondent
    Carlos O Acosta

    US Agent

    Business Name
    Omni-Guide Holdings, Inc.
    Contact Name
    Carlos Acosta
    Address
    43 Manning Road
    City
    Billerica
    State
    MA
    ZIP
    01821
    Country
    US
    Email
    [email protected]
    Phone
    617 5514400 ext. 563

    Products

    Device Name Product Code
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    FelxGuard

    Establishment Types

    Manufacture Medical Device