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510(k) Data Aggregation

    K Number
    K222372
    Device Name
    Kowa SL-19
    Manufacturer
    Kowa Company, Ltd.
    Date Cleared
    2022-11-21

    (108 days)

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

    Kowa Company, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KOWA SL-19 is 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 affect the structural properties of the anterior eye segment.
    Device Description
    The KOWA SL-19 is a non-invasive ophthalmic device that is able to illumination, magnification and observation of the human eye. Illumination light that emitted from a white light source is applied to the eyeball, Refractive media, Eye Anatomy, Ocular Adnexa, Iris, etc. are magnified and observed with a binocular microscope. Fluorescence of the cornea, conjunctiva, etc. can be observed by irradiating background illumination light and irradiating blue illumination light with a built-in light source. The background White LED function is added to the KOWA SL-19. The blue filter with white LED for the predicated device is removed, and this function is replaced by blue LED for the KOWA SL-19. Duration of illumination is lengthened from 140 min to 360 min from predicate device to the KOWA SL-19 due to replace the battery type from AAA battery to AA battery.
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    K Number
    K191945
    Device Name
    KOWA nonmyd 8
    Manufacturer
    Kowa Company, Ltd.
    Date Cleared
    2019-09-10

    (50 days)

    Product Code
    HKI
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    Kowa Company, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KOWA nonmyd 8 is indicated for true color, infrared and fundus autofluorescent (FAF) imaging of a human retina without the use of a mydriatic agent.
    Device Description
    The KOWA nonmyd 8 is an instrument that enables retinal examination and retinal image capturing using infrared rays without requiring the patients to take any mydriatics. The KOWA nonmyd 8 is used with KOWA VK-2s software (510(k) number is K190056) which is designated filing software installed in a computer and enables to save, register or print the captured images. The KOWA nonmyd 8 has Color mode and FAF mode for photographing. Those are the functions to capture a normal color image and the Fundus Autofluorescence (FAF) image.
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    K Number
    K190573
    Device Name
    KOWA DR-1a
    Manufacturer
    Kowa Company, Ltd.
    Date Cleared
    2019-06-04

    (90 days)

    Product Code
    HKI
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    Kowa Company, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KOWA DR-1a is an ocular surface interferometer, which is an ophthalmic imaging device that is intended for use by physician in adult patients to observe and record a video image of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented.
    Device Description
    The KOWA DR-1a is ocular surface interferometer, which is an ophthalmic imaging device that is intended for use by a physician in adult patients to observe and record a video image of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented. This instrument is intended to observe and record a video of the interference image with illuminating white light on the tear film layer. Users can replay the recorded image on the instrument's monitor to observe the condition of the tear film layer. In addition, using the image currently being replayed, users can measure the duration time by specifying 2 different point of time. This instrument has a function that allows users to output a video or a still image clipped from the video to an external personal computer.
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