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    K Number
    K992866
    Device Name
    OPTILITE IX LASER SURGERY ACCESSORIES
    Manufacturer
    CONVERGENT LASER TECHNOLOGIES
    Date Cleared
    1999-11-18

    (85 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    OPTILITE IX LASER SURGERY ACCESSORIES

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

    The OptiLITE IX Laser Surgery Accessories are indicated for incision/excision, ablation, and coagulation (homeostasis) when attached to cleared laser systems such as KTP, Nd: YAG, Argon, Diode, Ho:YAG, and Er:YAG wavelengths for the indications for which the lasers have been cleared.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for "OptiLITE IX Laser Surgery Accessories". It confirms that the device is substantially equivalent to a legally marketed predicate device.

    This document does not contain information regarding:

    • Acceptance criteria for device performance.
    • A study proving the device meets acceptance criteria.
    • Data provenance, sample sizes, expert qualifications, or ground truth details.
    • Any information related to AI or a multi-reader multi-case (MRMC) comparative effectiveness study.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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