BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)

    Reg #: 3005184723 · FEI: 3005184723 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    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
    K201268

    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
    Lens, Contact, (Disposable) MVN
    Lenses, Soft Contact, Daily Wear LPL

    Proprietary Names

    Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility