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510(k) Data Aggregation

    K Number
    K253007
    Device Name
    Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S)
    Manufacturer
    Guangzhou Potent Medical Equipment Joint-Stock Co. , Ltd.
    Date Cleared
    2025-11-20

    (62 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K243147
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    PT-OF-X-S Series Laser Fiber (Models PT-OF-A-S, PT-OF-B-S, PT-OF-C-S, PT-OF-D-S, PT-OF-E-S, PT-OF-F-S) is indicated for to deliver laser energy from a source to the target tissue in laser surgery applications, when used with any cleared/certified laser with wavelengths 1940nm - 2100nm equipped with SMA 905 standard connector.

    Device Description

    The PT-OF-X-S Series Laser Fiber is a reusable (up to 10 uses) optical fiber delivery system designed to transmit laser energy from compatible laser sources to surgical treatment sites. The device utilizes high-purity quartz glass core technology with total internal reflection principles to deliver precise laser energy for various surgical applications.

    The system features an SMA-905 standard connector for universal compatibility with cleared laser systems operating at wavelengths between 1940nm and 2100nm. Each fiber incorporates an integrated RFID module for usage tracking and cycle management, ensuring safe reuse within validated parameters.

    The device is supplied non-sterile and requires sterilization prior to use. It is designed for professional use in healthcare facilities by physicians familiar with laser surgical procedures.

    AI/ML Overview

    N/A

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