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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: FTC FDA class 2

    Light, Ultraviolet, Dermatological

    General, Plastic Surgery

    View full classification →

    A dermatological ultraviolet light is a device that emits ultraviolet radiation for therapeutic purposes, used in the treatment of skin conditions such as psoriasis, vitiligo, and other photosensitive dermatological disorders. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FTC, regulated under 21 CFR 878.4630, within the General, Plastic Surgery medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Ultraviolet Phototherapy Device
    308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)
    308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)
    UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)
    DT Controlled Phototherapy Equipment
    Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)
    3 Series NeoLux
    Enhanced AURORA™ Medical Diode System, and related accessories
    1 Series Phototherapy Equipment
    i8 Tanning Booth
    7 Series Phototherapy Device
    M Series Phototherapy Equipment
    308nm Excimer UV-light Skin Therapy System
    308nm Excimer System
    Psoria-Shield AURORA
    308nm Excimer System
    UV Radiation Treatment System
    Exciplex
    UV Phototherapy
    ClearLink Controlled Phototherapy Equipment
    308nm Excimer System
    Luma Light System
    Exciplex308nm
    Skylit Phototherapy System
    3 Series Phototherapy Unit
    ML24000 UVA-1 Phototherapy Cabinet
    GME ExSys 308
    Houva-NET Control System
    UV BIOTEK SINGLE PANEL, UV BIOTEK MULTI-DIRECTIONAL
    UV PHOTOTHERAPY
    PHILIPS UVA (/09) AND PHILIPS UVA-1 (/10) ULTRAVIOLET LAMPS
    MOBILE VERSA LIGHT
    SMART TOUCH UVTHERAPY MULTIPLE MACHINE
    4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES
    SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY
    ML24000 UVA-1 PHOTOTHERAPY UNIT
    PSORIA-LIGHT
    1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4
    LH-75 PHOTOTHERAPY SYSTEM
    LH-75T PHOTOTHERAPY SYSTEM
    ML24000 UVA-1 PHOTOTHERAPY CABINET
    VERSA LITE
    DERMAPAL WITH DIGITAL TIMER
    308 DERMATOLOGICAL EXCIMER SYSTEM
    RESOLVE UVB PHOTOTHERAPY SYSTEM
    PANOSOL II TRU-BLU, MODEL UBL-417
    3 SERIES PHOTOTHERAPY CABINET
    SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY
    VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100
    UVBIOTEK MODELS 3200B AND 4000B

    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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