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510(k) Data Aggregation
K Number
K151962Device Name
KBL Sunlamp Products (= Device Bundling name)
Manufacturer
KBL AG
Date Cleared
2016-09-15
(427 days)
Product Code
LEJ
Regulation Number
878.4635Why 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).
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