Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K151962
    Device Name
    KBL Sunlamp Products (= Device Bundling name)
    Manufacturer
    KBL AG
    Date Cleared
    2016-09-15

    (427 days)

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

    KBL AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KBL Sunlamp Products are over-the-counter tanning devices emitting ultraviolet light in the UVB and UVA region of the spectrum intended for tanning of the human skin of an adult person.
    Device Description
    KBL Sunlamp Products are whole-body tanning devices basically consisting of a mechanical structure equipped with artificial light sources producing ultraviolet light in the UVA and UVB region of the light spectrum. The UV light is intended for irradiation of any part of the living human body to induce skin tanning. The UVA light primarily generates a superficial tan which appears rapidly and is intensive but also fades more rapidly whereas the UVB light generates more long term tanning results. The user is either standing in the middle of the KBL Sunlamp Product if it is a vertical device (tanning tower) or lying on a bench if it is a horizontal device (tanning bed).
    Ask a Question

    Page 1 of 1