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510(k) Data Aggregation

    K Number
    K110205
    Device Name
    AAIO-7, AAIO WIRLESS
    Manufacturer
    APPASAMY ASSOCIATES
    Date Cleared
    2011-02-09

    (15 days)

    Product Code
    HLI
    Regulation Number
    886.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    APPASAMY ASSOCIATES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AAIO-7 & AAIO Wireless, is a head mounted Binocular Indirect ophthalmoscope designed to be Used by trained personnel for illuminating and viewing parts of the eye such as the Cornea and retina when used in conjunction with an ophthalmic lens. Binocular Indirect Ophthalmoscope provides an illumination system to direct appropriately, focused light into the eye in order to obtain an intermediate image of the fundus (retina) that is viewed by the observer to diagnose the eye.
    Device Description
    Binocular Indirect ophthalmoscope: AAIO-7 AAIO WIRELESS
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    K Number
    K082031
    Device Name
    APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES
    Manufacturer
    APPASAMY ASSOCIATES
    Date Cleared
    2008-07-31

    (14 days)

    Product Code
    HJO
    Regulation Number
    886.1850
    Why did this record match?
    Applicant Name (Manufacturer) :

    APPASAMY ASSOCIATES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Slit Lamp AIA-11 Series and AIA-12 Series are intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment.
    Device Description
    An AC-powered Slit Lamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects in to the patient's eye through a control diaphragm a thin, intense beam of light. Slit lamp examination is done to look at the front parts of the eye, including the cornea, lens, iris and the front section of the vitreous gel. Slit Lamp AIA-11 Series (AIA-11, AIA-11 3S, AIA-11 5S, AIA-11 Zoom) have the same operating characteristics and intended use. These models differ only in the number of Magnification. Slit Lamp AIA-12 Series (AIA-12, AIA-12 3S, AIA-12 5S, AIA-12 Zoom) have the same operating characteristics and intended use. These models differ only in the number of Magnification. The device and accessories are indicated as a noninyasive aid in the examination and diagnosis of the eye conditions. It is also used to fit the contact lenses.
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