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510(k) Data Aggregation

    K Number
    K092883
    Device Name
    LED LAMP OR OTHER
    Manufacturer
    INTRAVISTA MEDICAL SYSTEMS INC
    Date Cleared
    2009-12-18

    (91 days)

    Product Code
    HJO
    Regulation Number
    886.1850
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Vivid Light™ LED lamps for slit lamp biomicroscope are intended to be used as accessories for replacement of the 6V Tungsten bulb for Haag Streit's BM900, BQ900, BX900 and BP900 slit lamp biomicroscopes. Haag Streit's slit lamp biomicroscopes are indicated as noninvasive aid to the examination and diagnosis of eye conditions and in fitting of contact lenses.

    Device Description

    Vivid Light™ LED lamps for slit lamp biomicroscope

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Vivid Light™ LED lamp for slit lamp biomicroscope). This document primarily focuses on FDA's determination of substantial equivalence to a predicate device and regulatory compliance, rather than details about a specific study proving the device meets acceptance criteria.

    Therefore, the information required to answer your questions (acceptance criteria, device performance, study details, ground truth, expert qualifications, etc.) is not present in the provided text.

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