BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    Digital Prism Correction Feature (DPCF)

    K Number: K242058 · Decision Oct 21, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    12
    Review Days
    98

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    Basic Information

    Device Name
    Digital Prism Correction Feature (DPCF)
    K Number
    K242058
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1655
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Apple, Inc.
    Date Received
    July 15, 2024
    Decision Date
    October 21, 2024
    Product Code
    SCW
    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
    SCW Digital Prismatic Correction

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    Digital Prism Correction Feature (DPCF)

    FDA 510(k)
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