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
Bronzing Sun / 100w	FR73 T12 100W RS / RDC	FDA UDI	Class II	Active
Sunfire Power Window / 100w	F71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
Radiance Plus 7000 6.5 / 100-120w	FR71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
California Sun Mega Ehp 3300927305 / 120w	FR71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
Eternal Sun Ux / 160w	FR71 T12 160W VHO PH / BiPin	FDA UDI	Class II	Unknown
Radiance / 120w	F73 T12 100W PH / RDC	FDA UDI	Class II	Active
Velocity Select Plus / 100w	F71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
blueSunlight	FR75T12 / blueSunlight 1939 R / 200W	FDA UDI	Class II	Active
Sundash HRF / 20W	FR18 T8 PH / BiPin	FDA UDI	Class II	Unknown
Radiance 8000 7.5 / 160w	F73 T12 160W VHO RS / RDC	FDA UDI	Class II	Active
Bronzing Sun / 140w	FR59 T12 140W VHO PH / BiPin	FDA UDI	Class II	Active
Solerouge	F73T12 / SOLEROUGE / 100W / RDC	FDA UDI	Class II	Active
3.3 Vho	FR71T12 160W-R	FDA UDI	Class II	Unknown
Hi-Tan Vhr / 160w	FR71 T12 160W VHO PH / BiPin	FDA UDI	Class II	Active
ETERNAL SUN XP Gold / 120W	F73 T12 100W PH / RDC	FDA UDI	Class II	Unknown
pureSunlight	FR68T12 / pureSunlight 1723 R / 200W	FDA UDI	Class II	Unknown
Cleo Swift	FR71T12 CLEO SWIFT XPT-R 160W	FDA UDI	Class II	Unknown
Millennium M2	FR71 Bi-Pin 3.15 160-180W	FDA UDI	Class II	Active
Cosmolux Esp / 100w	FR73T12 / COSMOLUX ESP / 100-120W / RDC	FDA UDI	Class II	Active
Cosmolux Vhr-Tt / 160-200w	FR74 T12 160W VHO PH / RDC	FDA UDI	Class II	Active
Bermuda Gold Supreme 20 / 120w	FR71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
Radiance Hrf	FR18 T8 PH / BiPin	FDA UDI	Class II	Unknown
Perfect Bronze	FR59 T12 140W BI-PIN	FDA UDI	Class II	Unknown
Radiance 5k 5.0 / 100w	F71 T12 100W PH / BiPin	FDA UDI	Class II	Active
Radiance / R2 3.7 / 80w	FR59 T12 80W PH / BiPin	FDA UDI	Class II	Unknown
Bronzing Sun / 180w	FR79 T12 180W VHO PH / BiPin	FDA UDI	Class II	Unknown
smartSunlight	FRW68 T12 smartSunlight 1714R 200W	FDA UDI	Class II	Unknown
SUNFIRE Intensive R-UVA / 110W	FR75 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
smartSunlight	FRW75T12/KBL smartSunlight 1914 R 200W	FDA UDI	Class II	Active
Solar Rayz SR / 100W	F71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
smartSunlight	FRW68T12/KBL smartSunlight 1714 R 200W	FDA UDI	Class II	Unknown
Ets Elite Plus / 100w	FR71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
Sunfire Plus Power Window	F71 100W	FDA UDI	Class II	Unknown
CosmoLux	F25 T5 25W	FDA UDI	Class II	Active
Bronzing Sun Elite / 160w / Sm	FR71 T12 160W HO PH / BiPin	FDA UDI	Class II	Unknown
Radiance Jaguar 10.0 / 100w	F71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
Eternal Sun Xp Gold / 100w	F73 T12 100W RS / RDC	FDA UDI	Class II	Unknown
GOLDEN BRONZE Maximum / 100-120W	F71 T12 100W PH / BiPin	FDA UDI	Class II	Active
pureSunlight	FR68T12/KBL pureSunlight 1712 R 200W	FDA UDI	Class II	Active
Blush	FR71T12 / BLUSH / 100-120W	FDA UDI	Class II	Active
CosmoLux Lynx S3	FR79T12 200W	FDA UDI	Class II	Active
Pro Tech	FR71T12/ PRO TECH II / INTENSIVE R-UVA /100W	FDA UDI	Class II	Active
Elite Select / 120w	F73 T12 100W RS / RDC	FDA UDI	Class II	Unknown
Cosmolux	FR71T12 / Cosmolux VHR-XT / 160-200W	FDA UDI	Class II	Active
Xs Bronzing Power / 100w	F73 T12 100W RS / RDC	FDA UDI	Class II	Unknown
Cosmolux Lynx K1	FR75 T12 180-200W SM	FDA UDI	Class II	Unknown
Eternal Sun Xp*r / 200w	FR74 T12 160W VHO PH / RDC	FDA UDI	Class II	Unknown
Golden Bronze	FR75 T12 160-220W Golden Bronze 1.9M	FDA UDI	Class II	Active
Darque Tan / 100w	F71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
extraSunlight	FRW68T12 / extraSunlight 1711R / 200W	FDA UDI	Class II	Active

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