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510(k) Data Aggregation

    K Number
    K260108

    Validate with FDA (Live)

    Device Name
    L12 LED Light Source with AIM
    Manufacturer
    Stryker Endoscopy
    Date Cleared
    2026-02-12

    (29 days)

    Product Code
    OWN,FCS,FCW,GWG,NWB
    Regulation Number
    876.1500
    Type
    Special
    Panel
    General & Plastic Surgery
    Age Range
    0.083 - 120
    Reference & Predicate Devices
    K231854
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Upon intravenous administration of SPY AGENT GREEN (indocyanine green for injection, USP), the L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct) in adults and pediatric patients 12 to 17 years of age, using near-infrared imaging.

    Fluorescence imaging of biliary ducts with the L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.

    Additionally, the L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging.

    Upon interstitial administration of SPY AGENT GREEN, the L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable are used to perform intraoperative fluorescence imaging and visualization of the lymphatic system,including lymphatic vessels and lymph nodes.

    Upon administration and use of pafolacianine consistent with its approved label, the L12 LED Light Source with Advanced Imaging Modality and SafeLight™ Cable are used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

    The L12 LED Light Source with Advanced Imaging Modality is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

    Device Description

    The L12 LED Light Source with AIM is part of the Advanced Imaging Modality (AIM) System. The system is an endoscopic real-time 4K visible white light and near-infrared illumination and transillumination imaging system. Near-infrared illumination is used for fluorescence imaging using indocyanine green and pafolacianine injection. Near-infrared illumination is also intended for use during transillumination of the ureters using the IRIS Ureteral Kit during minimally invasive and open surgical procedures. The L12 LED Light Source is a light-generating unit designed to illuminate surgical sites in the following applications: visible light, near-infrared fluorescence, and near-infrared transillumination.

    AI/ML Overview

    N/A

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