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Found 33 results
510(k) Data Aggregation
K Number
K221523Device Name
Tanning Lamp
Manufacturer
Unilam Co., Ltd.
Date Cleared
2023-02-15
(265 days)
Product Code
LEJ
Regulation Number
878.4635Why did this record match?
Product Code :
LEJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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
K220500Device Name
Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT by Ergoline, Planet Fitness 46/3 HLT by Ergoline, Ergoline Vitality Pure Light 3, Ergoline Vitality Pure Light, Planet Fitness 50/4 PLT III by Ergoline, Planet Fitness 50/4 PLT by Ergoline, Planet Fitness 46/3 PLT by Ergoline, Planet Fitness 42/3 PLT by Ergoline
Manufacturer
JK-Holding GmbH
Date Cleared
2022-07-01
(129 days)
Product Code
LEJ
Regulation Number
878.4635Why did this record match?
Product Code :
LEJ
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 as well as a mechanical structure with a defined active surface. UV lamps emit different UV-A and UV-B proportions of the UV radiation. 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 long-term tanning results. Using traditional UV light with the combination of red and blue light the user indulges in a new luxurious tanning experience. Optimal tanning results are achieved due to the synergistic combination of light spectra.
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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?
Product Code :
LEJ
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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K Number
K190173Device Name
Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound
Manufacturer
JK-Holding GmbH
Date Cleared
2019-05-10
(98 days)
Product Code
LEJ
Regulation Number
878.4635Why did this record match?
Product Code :
LEJ
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 as well as a mechanical structure with a defined active surface.
UV lamps emit different UV-A and UV-B proportions of the UV radiation. 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 long-term tanning results. Traditional UV light with the addition of (beauty) red light results in a natural looking tan. Optimal tanning results are achieved due to the synergistic combination of light spectra.
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K Number
K183539Device Name
Ergoline Sunrise 7200 Hybrid Technology
Manufacturer
JK-Holding GmbH
Date Cleared
2019-04-08
(109 days)
Product Code
LEJ
Regulation Number
878.4635Why did this record match?
Product Code :
LEJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This sunlamp product is intended exclusively for aestetic 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 as well as a mechanical structure with a defined active surface. UV lamps emit different UV-A and UV-B proportions of the UV radiation. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly. UV-B radiation is primarily responsible for more long-term tanning results. The Ergoline Sunrise 7200 Hybrid Light Technology / Hybrid Technology provides tanning results by combining traditional UV light with red light in a synergistic combination of light spectra.
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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?
Product Code :
LEJ
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
K181455Device Name
ProSun sunlamp products, Luxura sunlamp products
Manufacturer
ProSun International LLC
Date Cleared
2018-09-10
(98 days)
Product Code
LEJ
Regulation Number
878.4635Why did this record match?
Product Code :
LEJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tanning Bed Systems are intended to provide tanning of the human skin.
Device Description
The primary technical components of sunlamp products are whole body tanning devices consisting of a mechanical frame with Ultraviolet (UV) lamps providing an artificial source of UV radiation. The UV light is intended for irradiation of the human body to induce skin tanning. The user of the proposed devices device either lies in the horizontal tanning bed or stands in the vertical tanning booth.
Skin tanning varies with skin type and as the 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 fades more rapidly. The UV-B radiation is primarily responsible for more longterm tanning results.
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K Number
K151721Device Name
FIJI SUN FLUORESCENT TANNING UNIT
Manufacturer
KDB INC. (DBA) SPERTI SUNLAMP
Date Cleared
2018-06-22
(1093 days)
Product Code
LEJ
Regulation Number
878.4635Why did this record match?
Product Code :
LEJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fiji Sun Fluorescent Tanning Unit device (FIJI Sun) is intended to provide ultraviolet light for the purpose of stimulating a tanning response in the skin.
Device Description
The FIJI Sun Fluorescent Tanning Unit (FIJI SUN) is a small tabletop sunlamp product which uses four Sperti brand ultraviolet lamps (model number: FRT20TI21BUHO) manufactured for KBD. The FIJI Sun Fluorescent Tanning Unit uses a mechanical timer with a maximum timer interval of 15 minutes and a minimum timer interval of one minute. The maximum timer interval error as a percent of that interval is +/- 6%. Output performance testing and FDA performance standards were used to determine the maximum timer interval and the recommended exposure schedule which is on the device labeling and in the user instructions. Two pair of protective eye wear are supplied with the device. The spectral transmittance to the eye of the protective eyewear is 0.0008 in the wavelength range from 200 nm to 320 nm and 0.0004 in the wavelength range from 320nm to 400 nm and is sufficient over the wavelengths greater that 400nm to enable the user to see clearly enough to reset the timer. In order for the product to fulfill its function it emits UV light In the wavelength range from 290 nm to 400 nm and the emission level is one SED (100 J/m²). The minimum use distance specified in the product labeling and the user instruction is 18 inches. Adequate directions for use, warnings and contraindications are included in user instructions provided with the device and in the device labeling. There is no software contained in the device. The device is sold as Over the Counter (OTC).
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K Number
K180581Device Name
UV Lamps for Sunlamp Products
Manufacturer
Feilo Sylvania Germany GmbH
Date Cleared
2018-06-22
(113 days)
Product Code
LEJ
Regulation Number
878.4635Why did this record match?
Product Code :
LEJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This ultraviolet lamp is intended for use in sunlamp products for tanning of human skin.
Device Description
The component ultraviolet lamp model family or part numbers are for use in sunlamp products to tan human skin. They fall into a generic class of UV lamps that have the same basic technological features, characteristics, except for power rating, diameter and length, with the exact same intended use. The UV sunlamp model family are for tanning human skin use. They vary in brand ID and unique lamp ratings accordingly. These sunlamps fit into a wavelength range of 200-710nm and operate from the end product ballast supply.
There are individual component sunlamps listed in the exhibit page. They are classified as low pressure, mercury rare gas discharge devices and generally have the same construction and technical principals of operation as that of a common fluorescent lamp. The UV lamps have a tubular glass envelope with internal surface coated with fluorescent phosphor. The sealed lamps include the composition and electrical means to activate the UV light within the wavelength specification. The construction is controlled by production procedures and test methods defined in the QMS. The UV radiation is controlled by these methods to assure safe use.
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K Number
K180576Device Name
Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select)
Manufacturer
LPI, Inc.
Date Cleared
2018-04-19
(45 days)
Product Code
LEJ, LEI
Regulation Number
878.4635Why did this record match?
Product Code :
LEJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended to be used for the tanning of human skin.
Device Description
The series of tanning bed/booths are available in four configurations. Units consist of LPI, Inc. branded and OEM tanning beds and booths.
- ESB -14, 16, 18, 24, and Oasis 36(booth)
- Solar Storm 16R, 24S, 24R, 24C, 32S, 32R, 32C, 36ST, 48ST(Booth)
- Solar Wave 16, 24
- . Sunco - 16XS, 24XS, 32XS, and 48Vertical (Booth)
Each configuration consists of a metal structure with lamps placed equally distant horizontally (booths) and arranged in manner to provide the tanner an even tan. The user of tanning beds lies down on the bench section and pulls down the canopy cover, which is equipped with a counterweighted gas springs/shocks in order for this section of the bed to open and close. The user of a tanning booth stands within the sections of the booth. The section of the booth (door) also has gas springs/shocks and wheels to close the door. All units have electronic type ballasts that powers the lamps. Each unit is also equipped with a settable electronic timer which is controlled by a time setting of 10, 15, or 20 minutes. Timers are also equipped with an "off" button to allow user to turn off the lamps any time prior to the duration of the set timer.
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