BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Extreme H20 Monthly

    Reg #: 3005184723 · FEI: 3005184723 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Acucon
    Registration Number
    3005184723
    FEI Number
    3005184723
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    7455 16th Street E Suite 108
    City
    SARASOTA
    State
    FL
    ZIP
    34243
    Country
    US

    Regulatory Submissions

    510(k) Number
    K051430

    Owner / Operator

    Firm Name
    ACUCON, LLC
    Operator Number
    10086820
    Address
    7455 16th Street E Suite 108
    City
    Sarasota
    State
    FL
    Postal Code
    34243
    Country
    US
    Correspondent
    Michelle Perkins

    Products

    Device Name Product Code
    Lenses, Soft Contact, Daily Wear LPL

    Proprietary Names

    Extreme H20 Monthly Ercon H20 Nature-Lens 1 Month Medilens Medical Comfort Extra soft contact lens for daily wear Extreme H2O 54% Extreme H20 54 Extreme H20 54 (Toric MC)

    Establishment Types

    Manufacture Medical Device