Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K222395
    Device Name
    Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo
    Manufacturer
    Ellex Medical Pty Ltd
    Date Cleared
    2022-11-02

    (86 days)

    Product Code
    HQF, HOF
    Regulation Number
    886.4390
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ellex Medical Pty Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In the YAG mode (Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo): -Iridotomy and iridectomy. -Posterior capsulotomy. -Posterior membranectomy. In the SLT mode (Tango Neo, Tango Reflex Neo) : -Selective Laser Trabeculoplasty (SLT)
    Device Description
    These devices are slit lamp based surgical laser instruments designed for use by ophthalmologists in clinics or an outpatient facility in a hospital or surgery. These systems are used to perform both Photodisruption procedures such as posterior capsulotomies, iridotomies, posterior membranectomies in the photodisruptor (YAG mode) and Selective Laser Trabeculoplasty (SLT mode) for the treatment of chronic open angle glaucoma. All these devices consist of the below main parts: Delivery Head, Microscope and Slit lamp Illumination, Console and Table Top, Joystick fire button, Total solution table, Display unit.
    Ask a Question
    K Number
    K212630
    Device Name
    Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo
    Manufacturer
    Ellex Medical Pty Ltd
    Date Cleared
    2021-12-16

    (119 days)

    Product Code
    HQF, HOF
    Regulation Number
    886.4390
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ellex Medical Pty Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In the YAG mode (Tango, Ultra Q, Ultra Q Reflex, Tango Reflex): -Iridotomy and iridectomy. -Posterior capsulotomy. -Posterior membranectomy. In the SLT mode (Tango, Solo, Tango Reflex): -Selective Laser Trabeculoplasty (SLT)
    Device Description
    These devices are slit lamp based surgical laser instruments designed for use by ophthalmologists in clinics or an outpatient facility in a hospital or surgery. These systems are used to perform both Photodisruption procedures such as posterior capsulotomies, iridotomies, posterior membranectomies in the photodisruptor (YAG mode) and Selective Laser Trabeculoplasty (SLT mode) for the treatment of chronic open angle glaucoma.
    Ask a Question
    K Number
    K190786
    Device Name
    Eye Prime
    Manufacturer
    Ellex Medical Pty Ltd.
    Date Cleared
    2019-04-11

    (15 days)

    Product Code
    IYO, ITX
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ellex Medical Pty Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Eye Prime is intended for ophthalmic imaging when the following conditions are present or suspected: •Cataracts •Retinal Detachment (separation of the retina from the middle coat of the eyeball) •Orbital Lesions •Tumors •Foreign Bodies •Inflammation •Vascular Irregularities
    Device Description
    The Eye Prime is a new, diagnostic ophthalmic ultrasound Track 1 device. Its function is to perform B-mode ultrasound scans. The system consists of 1) A console which supports 12 and 18MHz Posterior B scan probes and Anterior B- Scan. Ultrasound Bio-microscopy (UBM) probes with either 35 or 50MHz transducers. 2) A laptop which performs the image processing requirements of the system; provides the user interface for operating the device and viewing the resultant images. The laptop also provides data storage, export, archiving and networking for the device and includes the connection for footswitch.
    Ask a Question

    Page 1 of 1