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510(k) Data Aggregation

    K Number
    K001784
    Device Name
    VIRIDIS LASER
    Manufacturer
    COSMOS MEDICAL TECHNOLOGY
    Date Cleared
    2000-09-11

    (90 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    COSMOS MEDICAL TECHNOLOGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001704
    Device Name
    ATHOS
    Manufacturer
    COSMOS MEDICAL TECHNOLOGY
    Date Cleared
    2000-08-31

    (87 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    COSMOS MEDICAL TECHNOLOGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K983020
    Device Name
    COMPACT KTP LASER
    Manufacturer
    COSMOS MEDICAL TECHNOLOGY
    Date Cleared
    1998-11-25

    (86 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    COSMOS MEDICAL TECHNOLOGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The COMPACT-KTP-laser-is-intended-for-the-coagulation, ablation- vaporization, incision, excision, and/or cutting of soft tissue in dermatology. Examples of applications include: - Benign Vascular Lesions Port Wine Stains Erythrosis Couperosis Facial Telangiectasias Leg Veins - Micro-varicosities Benign Pigmented Lesions Senile Lentigo - The examples are not intended to be exhaustive or complete but-to serve as a general guide to surgeons.
    Device Description
    The COSMOS Medical Technology COMPACT KTP laser emits a beam of coherent light at 532 nanometers as do the predicate devices.
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