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510(k) Data Aggregation
K Number
K180555Device Name
Ergoline Prestige 1600 Hybrid Performance
Manufacturer
JK Holding GmbH
Date Cleared
2018-10-11
(224 days)
Product Code
LEJ
Regulation Number
878.4635Why 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 and a mechanical structure. Different UV sources intensities with characteristic UV-A and UV-B proportions result in cosmetic tanning of the human skin. 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 longterm tanning results.
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K Number
K151400Device Name
Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products
Manufacturer
JK HOLDING GmbH
Date Cleared
2015-09-16
(113 days)
Product Code
LEJ
Regulation Number
878.4635Why 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 and a mechanical structure. Different UV sources intensities with characteristic UV-A and UV-B proportions result in cosmetic tanning of the human skin. 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 longterm tanning results.
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