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
Eternal Sun Xp*r / 160w	FR71 T12 160W VHO PH / BiPin	FDA UDI	Class II	Unknown
pureSunlight	FR75T12 / pureSunlight 1916 R / 200W	FDA UDI	Class II	Active
Solarium Xlr / 160w	FR73 T12 160W VHO RS / RDC	FDA UDI	Class II	Active
extraSunlight	FR71T12 7 extraSunlight 1815 R / 200W	FDA UDI	Class II	Active
Cosmolux Vhr 200 / 2.0 M	FR79 T12 180W VHO PH	FDA UDI	Class II	Unknown
Sundazzler Premium / 160w	FR71 T12 160W VHO PH / BiPin	FDA UDI	Class II	Unknown
Radiance 8000 7.5 / 100w	F71 T12 100W PH / BiPin	FDA UDI	Class II	Active
Radiance R2 XLP 1.7	FR71T12 100-120W	FDA UDI	Class II	Active
Bronzing Sun Plus / 100w	F71 T12 100W PH / BiPin	FDA UDI	Class II	Active
Blush	FR71T12 / BLUSH / 160-200W	FDA UDI	Class II	Active
Eternal Sun Xp*r 9k90 /160w	FR71 T12 160W VHO PH / BiPin	FDA UDI	Class II	Unknown
Elite Select / 100w	F71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
Master Bronze / 160w	FR71 T12 160W VHO PH / BiPin	FDA UDI	Class II	Unknown
Express Tan Ho / 100w	F73 T12 100W RS / RDC	FDA UDI	Class II	Unknown
Cosmolux Vhr-200 1.8m	FR71 T12 160W VHO PH / BiPin	FDA UDI	Class II	Unknown
Solarium Vho / 160w	F72 T12 160W VHO RS / RDC	FDA UDI	Class II	Active
smartSunlight	smartSunlight 1974 R / 180W	FDA UDI	Class II	Active
Cleo Swift / 80w	FR59 T12 80W PH / BiPin	FDA UDI	Class II	Unknown
smartSunlight	FRW71 T12 smartSunlight 1804R 200W	FDA UDI	Class II	Active
Perfect Bronze	F73T12 100-120W 6.5	FDA UDI	Class II	Unknown
Bronzing Sun Plus / 100w	F73 T12 100W RS / RDC	FDA UDI	Class II	Active
Cosmolux Vhr 200 1.9 M / 180 - 200w	FR75 T12 180W VHO PH / BiPin	FDA UDI	Class II	Unknown
Cosmolux RA Plus / 40W	FR24 T12 40W-K PH / BiPin	FDA UDI	Class II	Active
smartSunlight	FRW75 T12 smartSunlight1914R 200W	FDA UDI	Class II	Unknown
HT 60/54 Plus 160W	FR71 T12 160W	FDA UDI	Class II	Unknown
Bronzing Sun Plus / 160w	BSP 71-T12-160-200W VS-R BI-PIN	FDA UDI	Class II	Active
Eternal Sun Xp*r 9k90 / 180-250w	FR79 T12 180W VHO PH / BiPin	FDA UDI	Class II	Unknown
pureSunlight	FR75T12 / pureSunlight 1910R / 180W	FDA UDI	Class II	Active
Golden Bronze Ii / 100w	F73 T12 100W RS / RDC	FDA UDI	Class II	Active
Suncapsule 250 Max / 180-250w	FR79 T12 180W VHO PH / BiPin	FDA UDI	Class II	Active
Radiance R2 Vip / 160w	FR72 T12 160W VHO RS / RDC	FDA UDI	Class II	Active
Golden Sun Plus HO LET 024.0202 / 100W	F71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
pureSunlight	FR68T12 / pureSunlight 1712 R / 200W	FDA UDI	Class II	Unknown
extraSunlight	F8WT5 / extraSunlight 0323 O	FDA UDI	Class II	Active
Euro Bronze Pro Mag 7.0 Plus / 100w	F73 T12 100W RS / RDC	FDA UDI	Class II	Unknown
Golden Sun	F71 T12 100W	FDA UDI	Class II	Active
Cosmolux	FR71T12 / COSMOLUX LYNX S10 / 200W	FDA UDI	Class II	Active
California Sun Premiere / 170w	FR71 T12 160W VHO PH / BiPin	FDA UDI	Class II	Unknown
Bronzing Sun / 160w	FR71 T12 160W VHO PH / BiPin	FDA UDI	Class II	Unknown
Genesis Hpr 15	HPR 15FR71-T12-CA-160W	FDA UDI	Class II	Unknown
Euro Sun Plus / 100w	F71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
Cosmolux Vlr 9k-90 / 100w	FR71 T12 100W PH / BiPin	FDA UDI	Class II	Active
Ets Elite Vzr / 160w	FR71 T12 160W VHO PH / Bipin	FDA UDI	Class II	Active
Radiance PLUS+ 7000 6.5 / 100-120W	F73 T12 100W RS / RDC	FDA UDI	Class II	Unknown
Cosmolux Esp-R / 100w	FR71T12 / COSMOLUX ESP-R / 100-120W	FDA UDI	Class II	Active
Darktan / 100w	FR71 T12 100W PH / BiPin	FDA UDI	Class II	Active
Radiance 7000 6.5 / 100w	F71 T12 100W PH / BiPin	FDA UDI	Class II	Active
Millenium 7000 6.5 / 100w	F71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
Eternal Sun Xp 2.0m / 180-250 W	FR79 T12 180W VHO PH / BiPin	FDA UDI	Class II	Unknown
Hi-Tan	F71T12 / HI-TAN MAX / 100W	FDA UDI	Class II	Active

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