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510(k) Data Aggregation
K Number
K191881Device Name
KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun
Manufacturer
KBL GmbH
Date Cleared
2019-10-28
(105 days)
Product Code
LEJ
Regulation Number
878.4635Why did this record match?
Applicant Name (Manufacturer) :
KBL GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
KBL Sunlamp Hybrid Products are over-the-counter tanning devices emitting ultraviolet light in the UVA and UVB region of the spectrum intended for tanning of the human skin of an adult person.
Device Description
KBL Sunlamp Hybrid Products are whole-body tanning devices basically consisting of a mechanical structure equipped with artificial light sources using the hybrid light technology. The hybrid light technology produces ultraviolet radiation and radiation in the visual range of the light spectrum. The UV light is intended for irradiation of any part of the living human body to induce skin tanning. The user is lying on a bench.
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