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510(k) Data Aggregation

    K Number
    K111643
    Device Name
    OPTO MITRA YELLOW LASER
    Manufacturer
    OPTO ELECTRONICA SA
    Date Cleared
    2011-11-03

    (143 days)

    Product Code
    HQF, HOF
    Regulation Number
    886.4390
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPTO ELECTRONICA SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated for use in photocoagulation of both anterior and posterior segments, including: - Retinal photocoagulation, panretinal photocoagulation and intravitreal . endophotocoagulation of vascular and structural abnormalities of the retina and choroids, including: - Proliferative and nonproliferative diabetic retinopathy - Choroidal neovascularization - Branch retinal vein occlusion - The treatment of choroidal neovascularization associated with wet age related macular degeneration Retinal tears and detachments - Retinopathy of prematurity - Iridotomy, iridectomy, and trabeculoplasty in angle closure glaucoma and open angle glaucoma Intended for use in ophthalmic surgical procedures.
    Device Description
    The Photocoagulator Opto Mitra Yellow Laser is equipment capable of making human retinal photocoagulation by laser application at 586nm (yellow laser). The coagulation (clotting) of tissue using a laser which produces light in the visible yellow (586nm) wavelength that is selectively absorbed by hemoglobin, the pigment in red blood cells, in order to seal off bleeding blood vessels. Photocoagulation has diverse uses such as, for example, in cancer treatment to destroy blood vessels entering a tumor and depriving it from nutrients; in the treatment of a detached retina, to destroy abnormal blood vessels in the retina, to treat tumors in the eye, etc. The equipment consists of three encoders which enable the physician to adjust the pulse duration, the laser power and the interval between successive pulses. All information is displayed on a color display 240x324 pixels TFT technology. On this display there is a touch-screen film responsible for the navigation software and by setting preferences, such as loudness, intensity laser sighting and display brightness. Physicians have the option of applying single pulses or pulse trains previously adjusted. Power levels ranging from 50mW up to 2000MW, with resolution of 10mW. The duration can be set between 100ms and 3000 ms with a resolution of 10ms. The interval between pulses can be set between 100ms and 3000ms with 10ms resolution or can be set to single pulse (in this case, the range is set to zero). The Opto Mitra Yellow Laser beam has a wavelength of 586nm, which is in the visible spectrum and is a yellow light. A red aiming beam is used to position the treatment Yellow beam prior to delivery. The Opto Mitra Yellow Laser is a solid state, Optical Pumped Semiconductor surgical laser. It's an instrument used in the photothermolysis (photocoagulation) of soft tissue at en emission wavelength of 586nm. Compatible delivery devices include: slit lamp adapters/, laser indirect ophthalmoscopes (LIO) and endoprobe. All these accessories are specific for Opto Mitra Yellow Laser.
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