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

    VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES

    K Number: K000457 · Decision May 9, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    234
    Registration Numbers
    235
    Same Product Code
    76
    Applicant Total
    5
    Review Days
    88

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    Basic Information

    Device Name
    VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES
    K Number
    K000457
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Retinalabs.Com
    Date Received
    February 11, 2000
    Decision Date
    May 9, 2000
    Product Code
    HMX
    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
    HMX Cannula, Ophthalmic

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    Other Clearances by Retinalabs.Com

    K Number Device Name
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    K000420 SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003