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510(k) Data Aggregation

    K Number
    K983277
    Device Name
    LIGHTSOURCE OR ILLUMINATOR MODEL I-100
    Manufacturer
    CUDA PRODUCTS CO.
    Date Cleared
    1998-12-16

    (90 days)

    Product Code
    HBI,FCR,FCW,FFS,HET
    Regulation Number
    878.4580
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LIGHTSOURCE OR ILLUMINATOR MODEL I-100

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To provide light for fiberoptic cables and instruments. Provide light for instrumentation via fiberoptic cables for use in surgical fields. For example: lightsource attaches to fiberoptic cable which is then attached to a headlight or microscope or video camera. The lightsource supplies light for the headlight or microscope or video camera.

    Device Description

    Lightsource or illuminator I-100

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a device called "Lightsource Model or Illuminator I-100". It primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities.

    None of the requested details regarding acceptance criteria, device performance, study designs (sample size, data provenance, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance), or training set information are present in the provided text.

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