BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Nuance Audio

    Reg #: 3011016506 · FEI: 3011016506 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LUXOTTICA GROUP S.P.A
    Registration Number
    3011016506
    FEI Number
    3011016506
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Piazzale Cadorna, 3
    City
    Milan Milano
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K243150

    Owner / Operator

    Firm Name
    Luxottica
    Operator Number
    10047811
    Address
    100 Greenwood Industrial Pkwy
    City
    McDonough
    State
    GA
    Postal Code
    30253
    Country
    US
    Correspondent
    Francesco Iavarone

    US Agent

    Business Name
    EssilorLuxottica
    Contact Name
    Domenico Bon
    Address
    One Icon
    City
    Foothill Ranch
    State
    CA
    ZIP
    92610
    Country
    US
    Email
    [email protected]
    Phone
    949 9007458

    Products

    Device Name Product Code
    Air-Conduction Hearing Aid Software SCR

    Proprietary Names

    Nuance Audio

    Establishment Types

    Manufacture Medical Device