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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: OLP FDA class 2

    Over-The-Counter Powered Light Based Laser For Acne

    General, Plastic Surgery

    View full classification →

    The Over-The-Counter Powered Light Based Laser For Acne (product code OLP) is a Class 2 device regulated under 21 CFR 878.4810 in the General, Plastic Surgery specialty (SU), cleared via 510(k). It is intended for over-the-counter use to treat patients with mild to moderate acne vulgaris by emitting energy in both the red and blue regions of the light spectrum. The device is not an implant or life-sustaining, and is reviewed by the General, Plastic Surgery panel.

    510(k) Clearances

    49 matches
    K Number
    Device Name
    LED Light Therapy Mask (RT01)
    LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)
    BLU TOTALE (Model: ENEOB852)
    PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT
    LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001
    LED Facial Mask
    The Luminance RED Acne Device
    Micro-current facial cold and hot service (model: TPML-100)
    Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine
    Shani Darden LED light therapy mask
    reVive Light Therapy Essentials
    MZ Skin LightMAX Supercharged LED Mask 2.0
    DemarkQ WOW, DemarkQ POP
    Aduro light therapy Handheld
    Omnilux CLEAR
    Looper (Model: ZX-579S)
    PDT-FACE
    Poly Clear
    dpl SpotLite
    LYFT
    LED Light Therapy Device
    Neutrogena Light Therapy Acne Mask+
    reVive Light Therapy LED Cleansing System
    SAPPHIRE, ELEVARE SAPPHIRE
    Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)
    Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37
    BC-001+ Acne Purifier
    LED Phototherapy Device
    Pulsaderm ACE-All Blue
    ESPADA Acne-Clearing Blue Light Pen
    Pulsaderm Acne Device
    Acne Light Therapy Wand
    Tria Sapphire
    Clear Bi-Light
    SONILASE BLUE, SONILASE BLUE-CLEAN, SONILASE BLUE-UV CLEAN PLUS
    Nutra Light Advanced
    LightStim for Acne/ LightStim for Acne Mini
    ULTRA RENEW PLUS
    NUTRA LIGHT BLUE
    LIGHTSTIM FOR ACNE/ LIGHTSTIM FOR ACNE MINI
    ILLUMASK ACNE LIGHT THERAPY MASK
    TANDA MINI SKINCARE SYSTEM
    SILKN BLUE
    CLEARFLASH AC2100 COSMETIC SYSTEM
    QUASAR CALYPSO
    NO!NO! SKIN
    QUASAR BLUE LIGHT THERAPY SYSTEM
    CLARO
    OMNILUX CLEAR-U

    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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