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

    BostonSight IC Corneal Lens, BostonSight IC Scleral Lens

    K Number: K153066 · Decision Feb 9, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    117
    Applicant Total
    1
    Review Days
    110

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    Basic Information

    Device Name
    BostonSight IC Corneal Lens, BostonSight IC Scleral Lens
    K Number
    K153066
    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
    Date Received
    October 22, 2015
    Decision Date
    February 9, 2016
    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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