BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)

    K Number: K242855 · Decision Jul 30, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    485
    Applicant Total
    1
    Review Days
    313

    Basic Information

    Device Name
    P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
    K Number
    K242855
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    E.O.S Co., Ltd.
    Date Received
    September 20, 2024
    Decision Date
    July 30, 2025
    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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