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

    Custom Stable Rigid Gas Permeable Scleral Contact Lens

    K Number: K213880 · Decision Jan 7, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    117
    Applicant Total
    3
    Review Days
    25

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    Basic Information

    Device Name
    Custom Stable Rigid Gas Permeable Scleral Contact Lens
    K Number
    K213880
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Valley Contax, Inc.
    Date Received
    December 13, 2021
    Decision Date
    January 7, 2022
    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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    Other Clearances by Valley Contax, Inc.

    K Number Device Name
    K202860 Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax V Kone (VK) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A)
    K170335 Custom Stable(TM) Rigid Gas Permeable Scleral Contact Lens