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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: ONF FDA class 2

    Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

    General, Plastic Surgery

    View full classification →

    The Powered Light Based Non-Laser Surgical Instrument With Thermal Effect (product code ONF) is a Class 2 surgical device regulated under 21 CFR 878.4810 in the General, Plastic Surgery specialty (SU), cleared via 510(k). It provides thermal effects using broad-spectrum sources such as intense pulsed light (IPL) and is typically indicated for use in plastic surgery, general surgery, and dermatology/aesthetic specialties. The device is eligible for third-party review and is not an implant or life-sustaining device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    IPL Treatment Device (MDSQMC-01)
    DEKA LOTUS
    Intense Pulsed Light Treatment System (LK-PT)
    MULA (K2-A1)
    Intense Pulsed Light System (ST-690)
    DEKA LOTUS
    Intensity Pulsed Light Therapy System
    Intense pulsed light therapy device
    Venus Versa PRO System
    Intense Pulsed Light System
    Intense Pulsed Light Treatment System
    Painless IPL System - KDT750
    10PL
    Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200
    Intense Pulsed Light Equipment
    IPL Hair Removal Device
    Aimanfun Lumea Comfort, A-2789/A-3588
    IPL Hair Remover, Model: G993, G996, G998 and G885
    Red Wave Hair Removal
    IPL Hair Removal Device (Model: KCA423)
    E>EyeC
    IPL Treatment Systems
    IPL + Diode Laser Machine
    Lucent : IPL
    Intense Pulsed Light Treatment System
    Multi-modality workstation
    SHINY RPL System
    Harmony XL Multi-Application Platform
    DUO
    IPL Therapy Machine
    Forma System, Forma Light System
    Venus Versa System
    Venus Versa System
    Shaser Skin Beauty Intense Pulsed Light System Family for Acne
    Exilite
    HARMONY LITE
    Mini me
    PLATINUMGMT IPL SYSTEM CLOUD
    ELLIPSE I2PL+/ELLIPSE MULTIFLEX+
    SHASER SKIN BEAUTY INTENSE PULSED LIGHT SYSTEM FAMILY
    A-TONE IPL SYSTEM
    LUMENA FH HAIR REMOVAL SYSTEM
    SHASER V-MINI 2 HAIR REMOVAL SYSTEM
    ME
    SHASER V-MINI RX
    MULTIFUNCTIONAL SERIES
    SHASER HRS2 RX HAIR REMOVAL SYSTEM
    SHASER V-MINI HAIR REMOVAL SYSTEM
    INMODE SR IPL DEVICE
    ACLEARA, THERACLEAR

    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.

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