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510(k) Data Aggregation

    K Number
    K040209
    Device Name
    IRIS MEDICAL IQ 810 PHOTOCOAGULATOR
    Manufacturer
    IRIDEX CORP.
    Date Cleared
    2004-09-20

    (234 days)

    Product Code
    HQF,GEX
    Regulation Number
    886.4390
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K020374
    Predicate For
    K032676,K072643,K081623
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The IQ 810 is indicated for retinal photocoagulation, laser trabeculoplasty, transscleral cvclophotocoagulation, transscleral retinal photocoagulation, iridotomy, and other laser diode treatments. The following are examples of applications for the IQ 810 laser systems.

    ConditionTreatment
    Diabetic Retinopathy Nonproliferative Retinopathy Macular Edema Proliferative RetinopathyPanretinal Photocoagulation (PRP); Focal and Grid Laser Treatments
    Glaucoma Primary Open Angle Closed Angle Refractory Glaucoma(recalcitrant/uncontrolled)Laser Trabeculoplasty; Iridotomy;Transscleral Cyclophotocoagulation(TSCPC)
    Retinal Tears, Detachments, and HolesTransscleral Retinal Photocoagulation(TSRPC); Focal and Grid LaserTreatments
    Lattice DegenerationPRP; Focal and Grid Laser Treatments
    Age-related Macular Degeneration (AMD)with Choroidal Neovascularization (CNV)Focal and Grid Laser Treatments
    Intra-Ocular Tumors Choroidal Hemangioma Choroidal Melanoma RetinoblastomaFocal and Grid Laser Treatments
    Retinopathy of PrematurityPRP; TSRPC; Focal and Grid LaserTreatments
    Sub-Retinal (choroidal) NeovascularizationFocal and Grid Laser Treatments
    Central and Branch Retinal Vein OcclusionPRP; Focal and Grid Laser Treatments
    Device Description

    The IQ 810 is a semiconductor diode laser system that delivers infrared 810 nm laser light intended to be used for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and iridotomy. Visible red (630-650 nm) semiconductor diode laser is used for aiming.

    AI/ML Overview

    The provided document is a 510(k) premarket notification decision letter from the FDA regarding the IRIS Medical® IQ 810 Diode Laser. This type of document establishes substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical or performance study.

    Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. Specifically:

    • No acceptance criteria table or reported device performance is present.
    • No sample sizes for test sets, data provenance, or details about the ground truth establishment for a study are provided. This is because no such study is described.
    • No information on experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance is included.
    • No training set details are mentioned.

    The document states:

    • "Non-Clinical performance Data: None"
    • "Clinical performance Data: None"

    The substantial equivalence determination is based on the device's technological characteristics and its intended use being similar to predicate devices, namely the IRIDEX Corporation's IRIS Medical OcuLight SLx Laser Photocoagulator (K020374). The letter concludes that the IQ 810 is "substantially equivalent to predicate devices currently legally marketed for the indication of retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and iridotomy."

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