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

    Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)

    K Number: K233221 · Decision Feb 6, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    472
    Applicant Total
    1
    Review Days
    131

    Basic Information

    Device Name
    Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)
    K Number
    K233221
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Metro Optics of Austin, Inc.
    Date Received
    September 28, 2023
    Decision Date
    February 6, 2024
    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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