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510(k) Data Aggregation

    K Number
    K162067
    Device Name
    VX130 Ophthalmic Diagnostic Device
    Manufacturer
    LUNEAU SAS
    Date Cleared
    2017-04-24

    (272 days)

    Product Code
    HKX, MXK
    Regulation Number
    886.1930
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUNEAU SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Measuring the refraction of the eye giving both lower and higher order aberrations Measurement of the shape of the cornea Retro-illumination imaging of the eye Measuring the intraocular pressure without contacting the eye for glaucoma evaluation. Photographing the eye and taking images of the eye to evaluate the thickness of the central cornea. Full corneal thickness map. Scheimpflug imaging. Anterior chamber imaging. Pupil image. Image of the cornea relative to the iris.
    Device Description
    The VX130 is a multifunctional ophthalmic diagnostic device. The VX130 combined wavefront aberrometer, corneal topographer, cataract screening device, Scheimpflug pachymeter, and non-contact tonometer is a single platform that contains five different measurement units. The wavefront aberrometer works on the Shack-Hartmann principle and is used as an advanced autorefractometer that measures both lower and higher order aberrations of the eye. Retro illumination is used to image ocular opacities. The corneal topographer uses a Placido disk to measure keratometry and the detailed shape of the cornea. A linear scanning Scheimpflug pachymeter measures the thickness of the cornea by illuminating it with a slit of light and photographing it using the Scheimpflug technique. Anterior and posterior corneal shape are also measured from the Scheimpflug images. An air puff non-contact tonometer is included for measurement of the intraocular pressure. The device is fully automated and a number of different measurements can be performed by a single command including alignment and focusing.
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    K Number
    K143086
    Device Name
    VX120 Ophthalmic Diagnostic Device
    Manufacturer
    LUNEAU SAS
    Date Cleared
    2015-06-01

    (217 days)

    Product Code
    HKX, HKO, MXK
    Regulation Number
    886.1930
    Why did this record match?
    Applicant Name (Manufacturer) :

    LUNEAU SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VX120 is a multi-function diagnostic device combining wavefront aberometer, corneal topographer, retro-illuminator, tonometer and pachymeter, indicated for: Measuring the refraction of the eye giving both lower and higher order aberrations Measuring the shape of the comea Retro-illumination imaging of the eye Measuring the intraocular pressure without contacting the eye for glaucoma evaluation Photographing the eye and taking images of the eye to evaluate the thickness of the cornea.
    Device Description
    The VX120 is a multifunctional ophthalmic diagnostic device. The VX120 combined wavefront aberrometer, corneal topographer, retro illumination device, Scheimpflug pachymeter, and non-contact tonometer is a single platform that contains five different measurement units. The wavefront aberrometer works on the Shack-Hartmann principle and is used as an advanced autorefractometer that measures both lower and higher order aberrations of the refraction of the eye. Retro illumination is used to image ocular opacities. The corneal topographer uses a Placido disk to measure keratometry and the detailed shape of the cornea. The Scheimpflug pachymeter measures the thickness of the central cornea by illuminating it with a slit of light and photographing it using the Scheimpflug technique. An air puff non-contact tonometer is included for measurement of the intraocular pressure. The device is fully automated and a number of different measurements can be performed by a single command including alignment and focusing.
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