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510(k) Data Aggregation

    K Number
    K003512
    Device Name
    LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II
    Manufacturer
    A.R.C. LASER AG
    Date Cleared
    2001-02-08

    (86 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    A.R.C. LASER AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    Ask a specific question about this device

    K Number
    K002986
    Device Name
    A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5
    Manufacturer
    A.R.C. LASER AG
    Date Cleared
    2000-11-29

    (65 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    A.R.C. LASER AG

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

    Ask a specific question about this device

    K Number
    K001511
    Device Name
    O-LAS OPHTHALMIC PHOTODISRUPTOR
    Manufacturer
    A.R.C. LASER AG
    Date Cleared
    2000-07-19

    (65 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    A.R.C. LASER AG

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

    Ask a specific question about this device

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