BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇱 Israel

    AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND

    K Number: K132042 · Decision Apr 28, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    712
    Registration Numbers
    712
    Same Product Code
    54
    Applicant Total
    1
    Review Days
    300

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    Basic Information

    Device Name
    AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND
    K Number
    K132042
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4750
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    X6d, Ltd.
    Date Received
    July 2, 2013
    Decision Date
    April 28, 2014
    Product Code
    HOY
    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
    HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

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