BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Doctor Smile A-810 B-980 Lasers

    Reg #: 3007689729 · FEI: 3008697515 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LAMBDA SPA
    Registration Number
    3007689729
    FEI Number
    3008697515
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    via dell impresa 1
    City
    Brendola Vicenza
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K091562

    Owner / Operator

    Firm Name
    LAMBDA SPA
    Operator Number
    10029199
    Address
    via dell'Impresa
    City
    Brendola
    State
    Vicenza
    Postal Code
    36040
    Country
    IT
    Correspondent
    Francesco Beltrame

    US Agent

    Business Name
    Piezosurgery Inc. DBA Mectron North America
    Contact Name
    Richelle Braun
    Address
    4115 Leap Rd
    City
    Hilliard
    State
    OH
    ZIP
    43026
    Country
    US
    Email
    [email protected]
    Phone
    817 6021363

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    Doctor Smile A-810 B-980 Lasers Helios Laser HL5

    Establishment Types

    Manufacture Medical Device