Question 1

What types of medical devices does Narva Lichtquellen GmbH + Co KG manufacture?

Accepted Answer

Narva Lichtquellen GmbH + Co KG specializes in ultraviolet tanning devices. These include handheld units like the BRONZING SUN GOLD (200W) and capsule-style lamps such as the SUN CAPSULE. The company also produces variable-wattage systems, including the GOLDARIUM SP (100-120W) and RADIANCE R2 3.7, as well as specialized models like the VELOCITY HI-WATT (120W) and long-life bulbs such as the COSMOSTAR LONGLIFE (100W). These devices are designed for indoor tanning purposes.

Question 2

Where is Narva Lichtquellen GmbH + Co KG based?

Accepted Answer

Narva Lichtquellen GmbH + Co KG is based in the United States. The company operates from this location while developing and manufacturing its ultraviolet tanning devices, ensuring compliance with applicable domestic and international standards for such equipment.

Question 3

Which regulatory registries list Narva Lichtquellen GmbH + Co KG’s devices?

Accepted Answer

Narva Lichtquellen GmbH + Co KG’s ultraviolet tanning devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify the company’s products, including models like the DARK TAN II (100W) and GOLDEN BRONZE Plus (160W), under the regulatory framework.

Question 4

How are Narva Lichtquellen GmbH + Co KG’s ultraviolet tanning devices classified?

Accepted Answer

Narva Lichtquellen GmbH + Co KG’s ultraviolet tanning devices are classified as Class II under regulatory frameworks. This classification is typically assigned to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as the BRONZING SUN GOLD (200W) or RADIANCE BLACK (100W).

Question 5

What distinguishes Narva’s ultraviolet tanning devices from others in the market?

Accepted Answer

Narva’s ultraviolet tanning devices are distinguished by their diverse range of wattage options, including fixed-wattage models like the DARK TAN II (100W) and adjustable systems like the GOLDARIUM SP (100-120W). The company also offers specialized designs, such as compact capsule-style lamps (e.g., SUN CAPSULE) and high-wattage bulbs (e.g., VELOCITY HI-WATT 120W), catering to different user preferences and indoor tanning setups. These variations help address specific market needs while maintaining compliance with regulatory standards.

Device	Model / Reference	Registries	Class	Status
Master Bronze / 100w	FR71 T12 100W PH / BiPin	FDA UDI	Class II	Active
Perfect Bronze	FR73T12 LET 160W 3.5	FDA UDI	Class II	Unknown
Bermuda Gold Plus / 140w	FR59 T12 140W VHO PH / BiPin	FDA UDI	Class II	Unknown
Ergoline SR Super Power	FR71T12 100W-R	FDA UDI	Class II	Unknown
Eternal Sun Xp Gold / 80w	F59 T12 80W PH / BiPin	FDA UDI	Class II	Unknown
Ergoline Turbo Power / 200w	FR79 T12 180W VHO PH / BiPin	FDA UDI	Class II	Unknown
pureSunlight	FR68T12 / pureSunlight 1713 R / 200W	FDA UDI	Class II	Unknown
Cosmolux LS / 25W	F25 T5 25W PH / BiPin	FDA UDI	Class II	Unknown
pureSunlight	FR75T12 / pureSunlight 1900 R / 180W	FDA UDI	Class II	Active
Cosmolux 9k90 / 180w-200w	FR79 T12 180W VHO PH / BiPin	FDA UDI	Class II	Unknown
Golden Bronze / 100w	FR73 T12 100W RS / RDC	FDA UDI	Class II	Active
Hollywood Tans 42 / 100w	F71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
smartSunlight	FRW75T12 / smartSunlight 1925 R / 180W	FDA UDI	Class II	Unknown
Dark Tan Elite / 100w	F71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
Radiance +5000 5.0 / 100w	FR73 T12 100W RS / RDC	FDA UDI	Class II	Unknown
Cosmolux Esp / 100w	Cosmolux ESP F73T12 100-120W RDC	FDA UDI	Class II	Active
Velocity / 100w	F71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
CosmoLux Lynx S1	FR71 120W	FDA UDI	Class II	Active
Solarium Vho / 160w	F73 T12 160W VHO RS / RDC	FDA UDI	Class II	Active
Golden Goddess Bronzer HP	FR73T12 100-120W	FDA UDI	Class II	Unknown
Radiance 7000 6.5 / 80w	F59 T12 80W PH / BiPin	FDA UDI	Class II	Active
Millennium M2	FR71 Bi-Pin 3.15 160-180W	FDA UDI	Class II	Unknown
California Sun Ultra 3300927303 / 105w	F71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
Golden Bronze / 100-120w	FR71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
Radiance R3 Vho / 200w	FR74 T12 160W VHO PH / RDC	FDA UDI	Class II	Active
Bronzing Sun Mag / 100w	FR71 T12 100W PH / BiPin	FDA UDI	Class II	Active
Hi Sun 9vk Vho / 160w / Sm	F72 T12 160W HO RS / RDC	FDA UDI	Class II	Unknown
extraSunlight	FRW68T12 / extraSunlight 1711R / 200W	FDA UDI	Class II	Active
Cosmosun R / 160w	FR71 T12 160W VHO PH / BiPin	FDA UDI	Class II	Unknown
Bronzing Sun Hpk90 / 200w	FR71 T12 160W VHO PH / BiPin	FDA UDI	Class II	Active
Xs Bronzing Power / 100w	F71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
Genesis Hyperbronze / 170-200w	FR71 T12 160W VHO PH / BiPin	FDA UDI	Class II	Active
Cosmolux Vhr 9k90 / 160w	FR71 T12 160W VHO PH / BiPin	FDA UDI	Class II	Unknown
Cleo Advantage Xpt / 160w	FR71 T12 160W VHO PH / BiPin	FDA UDI	Class II	Active
Cosmolux Vho / 160w	F71 T12 100W PH / BiPin	FDA UDI	Class II	Active
Cosmolux Esp-R / 100w	FR71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
Eurobronze Mag 7.0 Plus / 160w / Sm	F72 T12 160W HO RS / RDC	FDA UDI	Class II	Unknown
RubelLite	FR79T12 / RubelLite / 180-250W	FDA UDI	Class II	Active
Cosmolux Vhr-Tt / 160w	FR73 T12 160W VHO RS / RDC	FDA UDI	Class II	Active
Radiance / 25W	F25 T5 25W PH / BiPin	FDA UDI	Class II	Unknown
Cleo Advantage 808 / 100w	F71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
Solarium Xlr / 160w	FR72 T12 160W VHO RS / RDC	FDA UDI	Class II	Active
Cleo Advantage 808 Xpt	FR71 T12 160W-R	FDA UDI	Class II	Unknown
Inferno BL XP / 100W	F71 T12 100W PH / BiPin	FDA UDI	Class II	Active
HI SUN 9VK Solar Series 1 / 100W	F71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
Velocity Vs-R / 160w	FR71 T12 160W VHO PH / BiPin	FDA UDI	Class II	Unknown
Golden Goddess Bronzer XL 20-5.5	F71T12 100-120W	FDA UDI	Class II	Active
Cleo Advantage 808 / 100w	FR71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
Advantage 808 Xpt	FR71T12 160W-R	FDA UDI	Class II	Active
Hi Tan Vho / 160w	F73 T12 100W RS / RDC	FDA UDI	Class II	Active

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