BEUDAMED
    FDA Registration Active 🇫🇷 France

    OSYFIBRE 600

    Reg #: 3007064469 · FEI: 3007064469 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    LSO Medical
    Registration Number
    3007064469
    FEI Number
    3007064469
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    280 rue Salvador Allende
    City
    LOOS Nord
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K080731

    Owner / Operator

    Firm Name
    LSO Medical
    Operator Number
    10040129
    Address
    280 rue Salvador Allende
    City
    LOOS
    State
    Nord
    Postal Code
    59120
    Country
    FR
    Correspondent
    Philippe Rochon

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    OSYFIBRE 600 PHARAON EXO PHARAON ENDO CONTROL4+

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device