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
GENESIS SUPER POWER VHP20 Plus / 120W	FR71 T12 100W PH / BiPin	FDA UDI	Class II	Active
pureSunlight	FR68T12 / pureSunlight 1726 R / 160W	FDA UDI	Class II	Unknown
Millennium M2 3.15 / 160w-180w / Sm	FR71 T12 160W HO PH / BiPin	FDA UDI	Class II	Active
Ets Elite Cool Tone / 100w	F71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
Radiance R2 / 140w	FR59 T12 140W VHO PH / BiPin	FDA UDI	Class II	Active
Radiance 7000 6.5 / 100w	F73 T12 100W PH / RDC	FDA UDI	Class II	Active
Red Sun	FR71T12 / RED SUN PLUS / 100-120W	FDA UDI	Class II	Active
pureSunlight	FR75T12 / pureSunlight 1937 R / 180W	FDA UDI	Class II	Active
Bronzing Sun Elite / 160w / Sm	FR71 T12 160W HO PH / BiPin	FDA UDI	Class II	Active
Bronzing Sun Gold / 200w	FR71 T12 160W VHO PH / BiPin	FDA UDI	Class II	Active
Cosmolux Vlr-Tt / 80w	FR59 T12 80W PH / BiPin	FDA UDI	Class II	Active
pureSunlight	FR71T12 / pureSunlight 1825R / 160W	FDA UDI	Class II	Active
Velocity Select / 100w	F71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
Radiance 5000 5.0 / 80w	F59 T12 80W PH / BiPin	FDA UDI	Class II	Active
Cosmolux Vhr 200 / 2.0 M	FR79 T12 180W VHO PH	FDA UDI	Class II	Unknown
Red Sun	FR71T12 / RED SUN PLUS/ 160-200W	FDA UDI	Class II	Active
Magic Premium	FR71T12 OHM 23/100 R	FDA UDI	Class II	Unknown
Perfect Bronze	FR71T12 160W A-MAX	FDA UDI	Class II	Unknown
FabuTan 2.0	F71 T12 100W	FDA UDI	Class II	Active
extraSunlight	FR68 T12 extraSunlight 1711R 200W	FDA UDI	Class II	Active
Cosmolux Vlr / 100 W	FR71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
Bronzing Sun Vho / 160w	F71 T12 160W VHO PH / BiPin	FDA UDI	Class II	Active
Cleo Swift	FR71T12 CLEO SWIFT XPT-R 160W	FDA UDI	Class II	Active
blueSunlight	FR68T12 / blueSunlight 1729 R / 200W	FDA UDI	Class II	Active
Cosmolux Lynx K1	FR75 T12 180-200W SM	FDA UDI	Class II	Active
Cosmosun R / 100w	FR71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
pureSunlight	FR75T12 / pureSunlight 1990R / 200W	FDA UDI	Class II	Active
Cleo Advantage R / 100w	FR71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
Radiance R2 Hor 3.7 / 100-120w	FR71 T12 100W PH / BiPin	FDA UDI	Class II	Active
Genesis Vhp 15 / 120w	FR79 T12 120W PH / BiPin	FDA UDI	Class II	Unknown
Eternal Sun Ho / 100w	F71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
Elite Plus / 100w	F71 T12 100W PH / BiPin	FDA UDI	Class II	Active
Perfect Bronze 5.0	FR73T12 160W RDC	FDA UDI	Class II	Unknown
Velocity Extreme / 100w	F71 T12 100W PH / BiPin	FDA UDI	Class II	Active
Rio R Ho Let 024.0003 / 100w	FR71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
Cosmolux Vhr / 160w - 200w	FR71 T12 160W - 200W VHO PH / BiPin	FDA UDI	Class II	Active
Cosmolux	COSMOLUX VHR/ HP/250 MAX 180-250W FR 2.0M	FDA UDI	Class II	Active
Radiance 9000 8.5 100-120w	F73 T12 100W RS / RDC	FDA UDI	Class II	Active
Golden Sun Plus R	FR71T12 100W-R	FDA UDI	Class II	Unknown
Bellarium S / 100w	F73 T12 100W RS / RDC	FDA UDI	Class II	Unknown
Elite Ultra / 160w	FR71 T12 160W VHO PH / BiPin	FDA UDI	Class II	Unknown
Golden Bronze / 140w / Sm	FR59 T12 140W HO PH / BiPin	FDA UDI	Class II	Unknown
Ets Elite Ultra / 200w	FR79 T12 180W VHO PH / BiPin	FDA UDI	Class II	Unknown
UVA Plus / 25W	F25 T5 25W PH / BiPin	FDA UDI	Class II	Unknown
Cosmolux X / 15W	F12 T5 15W PH / BiPin	FDA UDI	Class II	Unknown
Cosmolux Vlr / 100 W	FR71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
Ho 100w	FR71T12 / 3.3 / HO / 100W (LET)	FDA UDI	Class II	Active
Meridian Bronzer / 100w	F59 T12 80W PH / BiPin	FDA UDI	Class II	Unknown
Cosmolux Vlr Tt / 100 W	FR71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
Solar Flare Max / 100w	F71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown

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