BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ClearSpec

    Reg #: 3010759301 · FEI: 3010759301 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    IMPACT INNOVATIONS LLC
    Registration Number
    3010759301
    FEI Number
    3010759301
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    138 NW 16th Street
    City
    Boca Raton
    State
    FL
    ZIP
    33432
    Country
    US

    Regulatory Submissions

    510(k) Number
    K143177

    Owner / Operator

    Firm Name
    Impact Innovations LLC
    Operator Number
    10046402
    Address
    123 NW 13th Street, STE 311
    City
    Boca Raton
    State
    FL
    Postal Code
    33432
    Country
    US
    Correspondent
    John Keady

    Products

    Device Name Product Code
    Dispenser, Liquid Medication KYX
    Lubricant, Patient KMJ

    Proprietary Names

    ClearSpec ClearSpec LED Illuminator KleenGel

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility