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

    BostonSight® Specialty Lenses

    K Number: K241571 · Decision Aug 14, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    117
    Applicant Total
    1
    Review Days
    75

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    Basic Information

    Device Name
    BostonSight® Specialty Lenses
    K Number
    K241571
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Foundation For Sight, Inc. D/B/A Bostonsight
    Date Received
    May 31, 2024
    Decision Date
    August 14, 2024
    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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