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510(k) Data Aggregation

    K Number
    K260632

    Validate with FDA (Live)

    Device Name
    LASER THERMAL THERAPY KIT
    Manufacturer
    Elesta S.P.A
    Date Cleared
    2026-03-17

    (19 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Special
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K230460,K181510
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LASER THERMAL THERAPY KIT is used to direct laser energy to soft tissue, to vaporize, ablate, necrotize or coagulate soft tissue through interstitial irradiation in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, at a wavelength of 1064nm.

    Device Description

    The LASER THERMAL THERAPY KIT is used to transfer laser energy from the laser unit to the tissue site for the treatment. The energy is transmitted via the fiber optic, which is introduced into the skin and tissue site percutaneously using the introducer needle. The LASER THERMAL THERAPY KIT is composed of a Fiber Optic for PLA (272 m core quartz-quartz fiber with distal end outer diameter 420 m and NA 0.2, and 2 m length) and an introducer needle (21G). The device is sterile and single use. Fiber optic and Introducer are packed individually.

    AI/ML Overview

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