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510(k) Data Aggregation

    K Number
    K991234
    Device Name
    THE ACME MEDICAL AESTHETIC ND:YAG LASER
    Manufacturer
    ACME MEDICAL, INC.
    Date Cleared
    1999-06-28

    (77 days)

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

    ACME MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For coagulation and hemostasis of vascular lesions.
    Device Description
    The Acme Medical Nd:YAG Aesthetic Laser is a long pulsed, solid-state infrared laser. It is intended to deliver laser energy for use in surgical applications requiring coagulation and hemostasis of vascular lesions. The Aesthetic Nd: YAG Laser produces a beam of infrared light at a wavelength of 1064nm. The system consists of: - a laser console; . - internal computer; . - control and display panel; . - permanently attached fiber optic delivery system; . - handswitch with the option of a footswitch; and . - fiber optic coupled handpiece and tip with cooling capability. .
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