BEUDAMED
    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: LEJ FDA class 2

    Booth, Sun Tan

    General, Plastic Surgery

    View full classification →

    A sun tan booth is a device that uses ultraviolet light sources to artificially tan the skin, regulated by the FDA as a device in the General, Plastic Surgery specialty with moderate risk considerations. It is classified as FDA Class 2, requiring 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. The product code is LEJ, regulated under 21 CFR 878.4635, in the General, Plastic Surgery specialty. Third-party review eligibility applies.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Tanning Lamp
    Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT by Ergoline, Planet Fitness 46/3 HLT by Ergoline, Ergoline Vitality Pure Light 3, Ergoline Vitality Pure Light, Planet Fitness 50/4 PLT III by Ergoline, Planet Fitness 50/4 PLT by Ergoline, Planet Fitness 46/3 PLT by Ergoline, Planet Fitness 42/3 PLT by Ergoline
    KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun
    Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound
    Ergoline Sunrise 7200 Hybrid Technology
    Ergoline Prestige 1600 Hybrid Performance
    ProSun sunlamp products, Luxura sunlamp products
    FIJI SUN FLUORESCENT TANNING UNIT
    UV Lamps for Sunlamp Products
    Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select)
    Sunrise 6200, Sunrise 7200
    HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux
    KBL Sunlamp Products (= Device Bundling name)
    IBL 5000 Tanning Booth
    Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy
    Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200
    HEX tanning booth
    T-32;T-40;T-44;T-52;T-72;TT-50
    uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS
    Sun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Capsule 60/225/2.0/6, Sun Capsule 54/225/2.0/5.5, Sun Capsule 54/200/1.8/6, Sun Capsule 54/160/1.8/6, Sun Capsule 49/225/2.0/5.5, Sun Capsule 49/220/1.9/5.5, Sun Capsule 48/220/1.9/6, Sun Capsule 48/200/1.86, Sun Capsule 48/180/1.9/6, Sun Capsule 48/160/1.8/6, Sun Capsule 44/180/2.0/5.5, Sun Capsule 44/180/1.9/5.5, Sun Capsule 39/180/1.9/5.5
    3400E series; E5400 series; E6400 series; Sundazzler series
    High Pressure Tanning Lamps
    BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux
    UV Lamps for Indoor Tanning Devices
    Suntanning Lamps
    Cosmedico Ultraviolet Lamps of Various Models
    Ultraviolet Lamps Intended for Use in Sunlamp Products (commonly known as metal halide sunlamps)
    Ultraviolet Sun Tanning Lamp
    Ultraviolet Sunlamps
    Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products
    Various Brands of Ultraviolet Lamps
    Tanning Lamp
    TANTHERA-T35
    HARPO SUNBED, SUN TANNING MACHINE
    ALPHA SOLAR SYSTEM TANNING BED
    ODYSSEY TAN 2000
    TAN AMERICA SUN UP
    CLEO TL80W PROFESSIONAL CLEO TL80W PROFESSIONAL R, CLEO TL100 W PROFESSIONAL
    SUNDASH
    ULTRAVIOLET LAMPS FOR TANNING
    ULTRABRONZ SERIES 400 TANNING BED
    ULTRABRONZ SERIES 800 (ECLIPSE) TANNING BED
    SUNBRONZE TANNING LAMPS
    FLUORESCENT T12 UVA TANNING LAMP
    EUROSUN MODELS - ES-2400, ES-VHO AND ES-16
    LIFESTYLE HOME TANNING UNITS
    SUNBRONZE SB24C/65 ULTRA
    REMINGTON TANFASTIC COUNTERTOP FACIAL TANNER
    SUNTANNING BED
    SHAW SUN SYSTEMS MODEL 1600

    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