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510(k) Data Aggregation

    K Number
    K973193
    Device Name
    LUXSCOPE
    Manufacturer
    LUXTEC CORP.
    Date Cleared
    1997-11-21

    (88 days)

    Product Code
    HQF
    Regulation Number
    886.4390
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUXTEC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LuxScope is indicated for panretinal photocoagulation and ablation of the ciliary processes.
    Device Description
    Not Found
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    K Number
    K970642
    Device Name
    TENOSCOPE
    Manufacturer
    LUXTEC CORP.
    Date Cleared
    1997-05-21

    (90 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUXTEC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The TenoScope is indicated for the visualization and diagnosis of a severed tendon which has retracted within its diagnosis of a severed conacial by non-invasive maneuvers.
    Device Description
    Not Found
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    K Number
    K970562
    Device Name
    TENOSNARE
    Manufacturer
    LUXTEC CORP.
    Date Cleared
    1997-05-14

    (90 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUXTEC CORP.

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