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510(k) Data Aggregation

    K Number
    K230722
    Device Name
    Eagle device
    Manufacturer
    BELKIN Vision Ltd.
    Date Cleared
    2023-12-08

    (267 days)

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

    BELKIN Vision Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Eagle device is indicated for use in selective laser trabeculoplasty (SLT).
    Device Description
    The Eagle device is a Q-switched, 532 nm-wavelength, frequency-doubled Nd:YAG laser that is intended for use in performing selective laser trabeculoplasty. The laser spots produced by the Eagle device have a 400 um spot size, a 3 ns pulse duration, and a 50-Hz pulse repetition rate. The sequence of laser spots consists of 120 spots in a predefined circumferential elliptical pattern delivered at a pre-defined pulse energy level. The spots are delivered through the limbus to the trabecular meshwork in a non-contact fashion, without the need for the use of a contact gonioscopy lens. The device automatically locates the treatment location. The treatment location may be adjusted slightly by the operator. Once confirmed by the operator, the device then automatically applies the laser treatment sequence to the limbal region of the eye, while the eye tracker compensates for any eye movement. The default energy setting is 1.8 mJ/pulse.
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