BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Spectrum Brands, Inc. (a Delaware Corporation)

    Reg #: 3005855240 · FEI: 3005855240 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    Spectrum Brands, Inc. (a Delaware Corporation)
    Registration Number
    3005855240
    FEI Number
    3005855240
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    3001 Deming Way
    City
    Middleton
    State
    WI
    ZIP
    53562
    Country
    US

    Regulatory Submissions

    510(k) Number
    K120080

    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
    Razor, Surgical LWK

    Proprietary Names

    iLIGHT Pro PLUS, iLIGHT Pro PLUS Quartz LumaRx MINI IPL Skin Beauty System model IPL2000 LumaRx Pro iLIGHT Elite Face and Body iLIGHT Ultra Face and Body LumaRx MINI IPL Skin Beauty System model IPL6800 iLIGHT Pro, Ilight Pro Premier

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility