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510(k) Data Aggregation
K Number
K161394Device Name
HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux
Manufacturer
Date Cleared
2017-07-06
(413 days)
Product Code
Regulation Number
878.4635Why did this record match?
Applicant Name (Manufacturer) :
Sportarredo Group S.C.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Sunlamp product intended for use to tan the skin.
Device Description
HPO Exotic: This model is a high pressure stand up appliance with tanning lamps located in four vertical columns. The high pressure lamps have a double filter: one blue cobalt filter in the inner part and one acrylic filter in the outer. The 1000 W lamps have an additional clear glass filter between the blue filters and the acrylic. The body frame is all in metal and it closes where it is possible all the electrical components. The body frame is covered by plastic thermoformed panels.
LP1: These suntan beds are three models with the same frame, aesthetic and with many common electrical parts. All the beds use the same low pressure lamps, the difference is the presence or not of the facial lamps. There are three versions: LP1-32/32EL, LP1-35/35EL, LP1-45/45EL. In all models the low pressure lamps are separated from the person by acrylic panels. The high pressure lamps have a double glass filter, one blue cobalt filter in the inner part and one clear filter in the outer. Every blue filter has a control switch. If the door is opened during the session or the filters are removed, the control switch interrupts the power supply on the control board and all lamps switch off. The body frame is all in metal and it closes where it is possible all the electrical components. The body frame is covered by plastic thermoformed panels.
LP2: This model is a bed with low pressure lamps in the base. The facial has 3 high pressure lamps. The low pressure lamps are separated from the person by acrylic panels. The high pressure lamps have a double glass filter: one blue cobalt filter in the inner part and one clear filter in the outer. Each blue filter has a control switch. If the door is opened during the session or the filter breaks the control switch interrupts the power supply and the lamp switches off.
LP3: These suntan beds are two models with the same frame, aesthetic and with many common electrical parts. The new models are similar to the current LP3, only the number of lamps was changed. There are two models: LP3-110 and LP3-140. Both models are beds with low pressure tanning lamps in the canopy and in the base and high pressure lamps in the facial area. The low pressure lamps are separated from the person by acrylic panels. The high pressure lamps have a double glass filter: one blue cobalt filter in the inner part and one clear filter in the outer.
Mastersun: This model is a bed with a high pressure tanning lamps located in five horizontal columns placed around the person body. Three columns are in the canopy, and two are in the bed, under the acrylic panel. The high pressure lamps have a double glass filter one blue cobalt filter in the inner part and one clear filter in the outer.
Vega: This model is a booth with low pressure lamps: the machine is mainly composed of three curved panels, two fixed and one is the door. Each panel has a set low pressure lamps separated from the person by acrylic panels.
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K Number
K152233Device Name
BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux
Manufacturer
Date Cleared
2016-01-27
(173 days)
Product Code
Regulation Number
878.4635Why did this record match?
Applicant Name (Manufacturer) :
Sportarredo Group S.C.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Sunlamp product intended for use to tan the skin.
Device Description
The submission covers several models of sunlamp products: B-Phase, HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, and Vega Lux. These devices are either stand-up units (booths) or beds with UV low pressure or high pressure lamps intended for tanning the skin. Some models include visible red-light lamps or facial tanning lamps. The lamps are separated from the user by acrylic panels or glass filters. The devices have metal body frames covered by plastic panels and include electrical components and control boards. Safety features like control switches that interrupt power if doors are opened or filters are removed are present in some models. Associated sunlamps and protective eyewear are also mentioned.
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