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510(k) Data Aggregation

    K Number
    K032599
    Device Name
    MEDICAL LASER TECHNOLOGIES, LLC MTL ERBIUM:YAG LASER SYSTEM
    Manufacturer
    MEDICAL LASER TECHNOLOGIES, LLC
    Date Cleared
    2003-10-29

    (65 days)

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

    MEDICAL LASER TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MLT Erbium: YAG Laser System device is designed specificially for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology.
    Device Description
    The Medical Laser Technologies, LLC MLT Erbium: YAG Laser System is an Er: YAG laser producing emission at a wavelength of 2940 nm. The laser consist of two interconnected sections: The cabinet which houses the power supply, the cooling system and the electronics, and; the umbilical cables and the hand piece, which houses the laser.
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