BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

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

    K Number: K201268 · Decision Oct 21, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    485
    Applicant Total
    1
    Review Days
    162

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    Basic Information

    Device Name
    Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
    K Number
    K201268
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Plexus Optix, Inc.
    Date Received
    May 12, 2020
    Decision Date
    October 21, 2020
    Product Code
    LPL
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

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

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