BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Extreme H2O 59% Xtra

    Reg #: 3005184723 · FEI: 3005184723 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    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
    K040303

    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 H2O 59% Xtra Extreme H2O Weekly Extreme H2O 59% Extreme H2O Daily Extreme H2O 59% (hioxifilcon A) Extreme H2O 59% Thin

    Establishment Types

    Manufacture Medical Device