BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    GPA (hexafocon A) Rigid Gas Permeable Contact Lenses

    K Number: K253822 · Decision Mar 27, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    117
    Applicant Total
    1
    Review Days
    119

    Basic Information

    Device Name
    GPA (hexafocon A) Rigid Gas Permeable Contact Lenses
    K Number
    K253822
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zhuhai Fitlens Medical Technology Co., Ltd.
    Date Received
    November 28, 2025
    Decision Date
    March 27, 2026
    Product Code
    HQD
    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
    HQD Lens, Contact (Other Material) - Daily

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