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510(k) Data Aggregation
K Number
K221523Device Name
Tanning Lamp
Manufacturer
Date Cleared
2023-02-15
(265 days)
Product Code
Regulation Number
878.4635Why did this record match?
Applicant Name (Manufacturer) :
Unilam Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
These devices are UV-B and UV-A lamps intended to provide ultraviolet radiation to tan the skin.
Device Description
The Unilam Tanning lamps are high-pressure metal-halide lamps, each comprised of a quartz glass bulb filled with metal halide, mercury, and argon gas, and equipped with 2 electrodes and an electrical connector, to provide ultraviolet light in order to tan the human body.
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K Number
K143043Device Name
Tanning Lamp
Manufacturer
Date Cleared
2015-04-02
(162 days)
Regulation Number
878.4635Why did this record match?
Applicant Name (Manufacturer) :
UNILAM CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Intended to provide ultraviolet light to tan the skin
Device Description
Tanning lamp is electronic products to be intended for irradiation of any part of the living human body, by ultraviolet radiation with wavelengths to induce skin tanning.
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