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510(k) Data Aggregation

    K Number
    K222933
    Device Name
    MYAH
    Manufacturer
    VISIA Imaging S.r.l.
    Date Cleared
    2023-06-29

    (276 days)

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

    VISIA Imaging S.r.l

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MYAH is intended to be used by an eye care professional: - to measure the axial length of the eye in a population age 5 and above - to capture and store digital images of the meibomian glands under near-infrared illumination in adult population. MYAH is not intended to be used in patients with cataracts.
    Device Description
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    K Number
    K211868
    Device Name
    MYAH
    Manufacturer
    VISIA imaging S.R.L.
    Date Cleared
    2022-03-01

    (258 days)

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

    VISIA imaging S.R.L

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MY AH is intended for measuring the axial length of the eye in a population age 5 and above and is intended for use under the care of an eye care professional. MYAH is not intended to be used in patients with cataracts.
    Device Description
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    K Number
    K160327
    Device Name
    ALADDIN HW3.0
    Manufacturer
    VISIA IMAGING S.R.L
    Date Cleared
    2016-10-05

    (243 days)

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

    VISIA IMAGING S.R.L

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ALADDIN HW3.0 is intended for biometric determination of the following ocular measures: axial length, corneal radius, corneal cylinder axis, anterior chamber depth (ACD), central corneal thickness (LT), white-to-white (WTW) and pupil diameter of the human eye. ALADDIN HW3.0 also measures corneal topography. For patients who are candidates for intraocular lens (IOL) implantation, ALADDIN HW3.0 also aids in the calculation of the appropriate IOL power and type to be implanted. ALADDIN HW3.0 is intended for use by physicians and eye-care professionals and may only be used under the supervision of a physician.
    Device Description
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    K Number
    K131567
    Device Name
    ALADDIN
    Manufacturer
    VISIA imaging S.r.l.
    Date Cleared
    2014-06-05

    (371 days)

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

    VISIA imaging S.r.l

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ALADDIN is intended for biometric determination of the following ocular measures: axial length, corneal radius, corneal cylinder axis, anterior chamber depth, white-to-white (WTW) and pupil diameter of the human eye. ALADDIN also measures corneal topography. For patients who are candidates for intraocular lens (IOL) implantation, ALADDIN also aids in the calculation of the appropriate IOL power and type to be implanted.
    Device Description
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