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510(k) Data Aggregation

    K Number
    K982113
    Device Name
    UMECO OPTIMA 694 RUBY LASER SYSTEM
    Manufacturer
    Date Cleared
    1998-09-30

    (106 days)

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

    UMECO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Umeco OPTIMA 694 system is intended for the use in the removal of blue/black tattoos and benign pigmented lesions in dermatology and plastic surgery.
    Device Description
    The Umeco OPTIMA 694 system is based on an optical cavity containing a Ruby laser rod. which is activated by means of the use of flashlamps. After the cavity, a red helium neon aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapuetic and aiming beams are guided down an articulated arm delivery system to a focusing handpiece. The laser is used in non-contact mode. The System is capable of emitting up to 2.2 Joules of light at 694 nm, with a nomimal pulsewidth of 20 nanoseconds. The laser is intended to be used for intended for the removal of blue/black tattoos and benign pigmented lesions in dermatology and plastic surgery. The Ruby laser system is designed with 3 major sub-systems: a) An articulated arm delivery system terminated in a focusing handpiece. b) An electronic power supply and interface circuitry. c} An optical chamber containing laser rod and laser cavity optics.
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