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510(k) Data Aggregation

    K Number
    K973576
    Device Name
    EPULSE MODEL 2940 ER:ASER ER:YAG LASER SYSTEM
    Manufacturer
    EPULSE TECHNOLOGIES, INC.
    Date Cleared
    1997-12-09

    (90 days)

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

    EPULSE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Er:aser™ laser is intended for coagulation, ablation, vaporization, or cutting of soft tissue in dermatology and plastic surgery, including aesthetic surgery and skin resurfacing.
    Device Description
    The Epulse laser is an erbium:YAG laser which emits its energy at 2.94 um.
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