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510(k) Data Aggregation

    K Number
    K220500
    Device Name
    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
    Manufacturer
    JK-Holding GmbH
    Date Cleared
    2022-07-01

    (129 days)

    Product Code
    LEJ
    Regulation Number
    878.4635
    Why did this record match?
    Applicant Name (Manufacturer) :

    JK-Holding GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This sunlamp product is intended exclusively for aesthetic tanning of the human skin, for one person at a time, at the age of 18 or above.
    Device Description
    The primary technical components of sunlamp products are artificial sources of UV radiation as well as a mechanical structure with a defined active surface. UV lamps emit different UV-A and UV-B proportions of the UV radiation. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly. The UV-B radiation is primarily responsible for more long-term tanning results. Using traditional UV light with the combination of red and blue light the user indulges in a new luxurious tanning experience. Optimal tanning results are achieved due to the synergistic combination of light spectra.
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    K Number
    K190173
    Device Name
    Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound
    Manufacturer
    JK-Holding GmbH
    Date Cleared
    2019-05-10

    (98 days)

    Product Code
    LEJ
    Regulation Number
    878.4635
    Why did this record match?
    Applicant Name (Manufacturer) :

    JK-Holding GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This sunlamp product is intended exclusively for aesthetic tanning of the human skin, for one person at a time, at the age of 18 or above.
    Device Description
    The primary technical components of sunlamp products are artificial sources of UV radiation as well as a mechanical structure with a defined active surface. UV lamps emit different UV-A and UV-B proportions of the UV radiation. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly. The UV-B radiation is primarily responsible for more long-term tanning results. Traditional UV light with the addition of (beauty) red light results in a natural looking tan. Optimal tanning results are achieved due to the synergistic combination of light spectra.
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    K Number
    K183539
    Device Name
    Ergoline Sunrise 7200 Hybrid Technology
    Manufacturer
    JK-Holding GmbH
    Date Cleared
    2019-04-08

    (109 days)

    Product Code
    LEJ
    Regulation Number
    878.4635
    Why did this record match?
    Applicant Name (Manufacturer) :

    JK-Holding GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This sunlamp product is intended exclusively for aestetic tanning of the human skin, for one person at a time, at the age of 18 or above.
    Device Description
    The primary technical components of sunlamp products are artificial sources of UV radiation as well as a mechanical structure with a defined active surface. UV lamps emit different UV-A and UV-B proportions of the UV radiation. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly. UV-B radiation is primarily responsible for more long-term tanning results. The Ergoline Sunrise 7200 Hybrid Light Technology / Hybrid Technology provides tanning results by combining traditional UV light with red light in a synergistic combination of light spectra.
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    K Number
    K173565
    Device Name
    Sunrise 6200, Sunrise 7200
    Manufacturer
    JK-Holding GmbH
    Date Cleared
    2018-02-14

    (89 days)

    Product Code
    LEJ
    Regulation Number
    878.4635
    Why did this record match?
    Applicant Name (Manufacturer) :

    JK-Holding GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This sunlamp product is intended exclusively for cosmetic tanning of the human skin, for one person at a time, at the age of 18 or above.
    Device Description
    The primary technical components of sunlamp products are artificial sources of UV radiation (UV lamps) and a mechanical structure. UV lamps emit different UV-A and UV-B proportions of the UV radiation. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly, the UV-B radiation is primarily responsible for more long-term tanning results.
    Ask a Question

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