BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LumaRx Pro

    Reg #: 3005855240 · FEI: 3005855240 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Spectrum Brands, Inc. (a Delaware Corporation)
    Registration Number
    3005855240
    FEI Number
    3005855240
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3001 Deming Way
    City
    Middleton
    State
    WI
    ZIP
    53562
    Country
    US

    Regulatory Submissions

    510(k) Number
    K141583

    Owner / Operator

    Firm Name
    Spectrum Brands, Inc. (a Delaware Corporation)
    Operator Number
    10034410
    Address
    3001 Deming Way
    City
    Middleton
    State
    WI
    Postal Code
    53562
    Country
    US
    Correspondent
    Tom Baumgard

    Products

    Device Name Product Code
    Powered Light Based Non-Laser Surgical Instrument With Thermal Effect ONF
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    LumaRx Pro iLIGHT Elite Face and Body

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198