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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: ILY FDA class 2

    Lamp, Infrared, Therapeutic Heating

    Physical Medicine

    View full classification →

    A Therapeutic Heating Infrared Lamp is a device used in Physical Medicine that emits infrared radiation to provide superficial radiant heat therapy to the body surface, used to relieve pain, reduce muscle spasm, increase local circulation, and facilitate tissue healing. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device before marketing. The product code is ILY, regulated under 21 CFR 890.5500, within the Physical Medicine medical specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)
    SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)
    LED Lip Perfector, model: ZC-05
    OLIZ LTB-1000A
    CytonPro-5000
    dermalux Flex MD
    AXON IR Heat Lamp
    HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System
    Softcure 96
    Bashan TDP Heat Lamp
    Vevazz LED Heat Lamp
    WS(TM) Far-Infrared Therapy Unit, Model KP-B210
    HeatLux Pro II
    Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3
    The Time Machine Series Lasers
    LightStim Professional LED Bed
    LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System
    Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)
    BioPhotas Celluma3
    Varaya Sport
    NuBrilliance Light Pain Therapy
    Phoenix Thera-Lase System
    LightStim for Pain LED Belt
    ZX2 Laser System
    HeatLux Pro I
    QK-SYSTEMIC THERAPEUTIC APPARATUS
    NEUROLUMEN PN-1000
    3B Laser 500, 3B Laser 200, LA-X P 500, LA-X P 200
    HILTHERA 4.0
    Applied BioPhotonics Phototherapy System ABPT1003
    Infrared Therapy System
    Power Twin21-50/Power Twin21-100
    VELASII THERAPY LASER SYSTEM
    OPTON PRO
    INFRARED HEATING DEVICE
    PHYSIOLASER OLYMPIC, SINGLE PROBES CW, CLUSTER PROBES CW, LIGHT NEEDLE, PHOTONIC SATELLITE
    LUMIX 3 PLUS AND LUMIX 3 ULTRA SYSTEM
    GALLIEON-1 MEDICAL LASER
    GIGALASER
    BIOPHOTAS CELLUMA
    CL10009 IR LASER
    LASER-STIM
    AVANT LASER
    BIOLIGHT BIODYNAM
    3B LASER NEEDLE
    STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM
    CYNOSURE 1064NM DIODE LASER
    TENDER TOUCH
    ASA LASER SH1
    BIOPHOTAS LIFELIGHT

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

    Popular Product Codes

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump