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510(k) Data Aggregation

    K Number
    K242397
    Device Name
    LYNX Photocoagulator
    Manufacturer
    Norlase Aps
    Date Cleared
    2024-10-25

    (73 days)

    Product Code
    HQF
    Regulation Number
    886.4390
    Type
    Traditional
    Panel
    Ophthalmic (OP)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LYNX Photocoagulator

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

    The Norlase LYNX Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text from the FDA 510(k) clearance letter for the LYNX Photocoagulator does not contain information on the acceptance criteria and the study that proves the device meets those criteria.

    This document is a clearance letter, which confirms that the FDA has found the device to be substantially equivalent to a legally marketed predicate device. It briefly touches on device classification, regulations, and mentions the intended use of the device.

    To describe the acceptance criteria and the study that proves the device meets them, I would need access to the actual 510(k) submission summary or a more detailed technical report which would typically include sections on performance testing, design specifications, and clinical or non-clinical data. The provided document only details the regulatory clearance, not the underlying performance data.

    Therefore, I cannot fulfill your request with the given input.

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