Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K002812
    Device Name
    IRIS RETRACTING PHACOEMULSIFICATION SLEEVE
    Date Cleared
    2000-11-08

    (61 days)

    Product Code
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICHAEL REYNARD, M.D.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
    Ask a Question

    Ask a specific question about this device

    K Number
    K964018
    Device Name
    PHACOILLUMINATOR - FIBEROPTIC SLEEVE
    Date Cleared
    1997-02-26

    (142 days)

    Product Code
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICHAEL REYNARD, M.D.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Provide illumination at surgical site.
    Device Description
    Clear silicone sleeve that transmits light originating from fiber optic channels contained in the phacofragmentation handpiece.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1