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510(k) Data Aggregation

    K Number
    K071896
    Device Name
    FOX 940, MODEL 940
    Manufacturer
    VALAM INC.
    Date Cleared
    2008-02-22

    (228 days)

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

    VALAM INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery
    Device Description
    Fox 940 is a diode laser with 940 nM wavelength and maximum 5 watt power output.
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