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510(k) Data Aggregation

    K Number
    K160392
    Device Name
    Novilase Laser Therapy System, Model LTS-2
    Manufacturer
    NOVIAN HEALTH, INC.
    Date Cleared
    2016-02-26

    (15 days)

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

    NOVIAN HEALTH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Novilase® Laser Therapy System (LTS-2) is indicated for the treatment of the breast, with tumor sizes up to 20 mm, and for general surgery procedures including incision and ablation of soft tissues; and coagulative necrosis and interstitial laser coagulation of soft tissues.
    Device Description
    The Novilase Laser Therapy System (Model LTS-2) is a second-generation laser-based system that uses laser ablation to destroy tumors via a minimally-invasive procedure
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