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510(k) Data Aggregation

    K Number
    K140368
    Device Name
    FAMILY OF DISPOSABLE LENSES
    Manufacturer
    SENSOR MEDICAL TECHNOLOGY, LLC
    Date Cleared
    2014-04-29

    (74 days)

    Product Code
    HKS
    Regulation Number
    886.1660
    Why did this record match?
    Product Code :

    HKS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sensor Medical Technology Family of Disposable Lenses are a family of diagnostic and therapeutic contact lenses used in the examination of the eye fundus, retina and iridocorneal and vitreous bodies and for the laser therapy of intraocular abnormalities.
    Device Description
    The Sensor Medical Technology Family of Disposable Lenses is a family of diagnostic and therapeutic contact lenses use for eve examination and therapy of intraocular abnormalities. The Family consists of 14 lenses - 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Mirror Lens, 3 Mirror Lens, Iridotomy Lens, Capsulotomy Lens, Retina 90 Lens, Retina 165 Lens, Retina 180 Lens, Indirect Lenses: 90 D, 78 D, 60 D, 28 D and 20 D. The Family of Ophthalmic Lenses is designed around the classic Goldmann contact lens. Each model lens is of similar design, but provide different optical elements to provide excellent visualization of the ocular anatomical areas for the particular intended use. When used in conjunction with a slit lamp, the ophthalmic lenses provide a binocular and stereoscopic view of the specific optical region of the eye. The lenses are provided sterile for single use.
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