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 Gold / 200w	FR79 T12 180W VHO PH / BiPin	FDA UDI	Class II	Active
Dark Tan Ii / 100w	F71 T12 100W PH / BiPin	FDA UDI	Class II	Active
Sun Capsule	FR79T12 / SUN CAPSULE 250 MAX VHR-XT / 180-250W	FDA UDI	Class II	Active
Goldarium Sp/ 100-120w	F71T12 / GOLDARIUM SP / 100-120W	FDA UDI	Class II	Active
Cosmolux Ra Plus / 100w	FR71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
Goldarium Sp / 80w	F59 T12 80W PH / BiPin	FDA UDI	Class II	Unknown
ETS Elite WARM TONE / 100W	F71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
Magic Premium	FR71T12 OHM 23/160 R	FDA UDI	Class II	Unknown
Cosmolux Lynx K1	FR75 T12 180W SM	FDA UDI	Class II	Unknown
Bermuda Gold Premium Plus / 160w	FR71 T12 160W VHO PH / BiPin	FDA UDI	Class II	Unknown
Eternal Sun Sx / 100w	F71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
Radiance R2 3.7 / 100-120w	FR73 T12 100W RS / RDC	FDA UDI	Class II	Active
Cosmolux Vhr / 160w	FR71 T12 160W VHO PH / BiPin	FDA UDI	Class II	Unknown
Sun Fusion Bl-Cc / 100w	F71 T12 100W PH / BiPin	FDA UDI	Class II	Active
Golden Bronze / 100-120w	F73 T12 100W PH / RDC	FDA UDI	Class II	Active
Eternal Sun Xp Gold / 120w	F71 T12 100W PH	FDA UDI	Class II	Unknown
Everglo / 100w	F71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
Radiance Black / 100w	F71 T12 100W PH / BiPin	FDA UDI	Class II	Active
Millennium M2	FR71 Bi-Pin 3.15 160-180W	FDA UDI	Class II	Unknown
Perfect Bronze	F73T12 100-120W 5.5	FDA UDI	Class II	Unknown
Velocity Hi-Watt / 120w	F73 T12 100W RS / RDC	FDA UDI	Class II	Active
GOLDEN BRONZE Plus / 160W	FR71 T12 160W VHO PH / Bipin	FDA UDI	Class II	Active
Radiance +5000 5.0 / 100w	F73 T12 100W RS / RDC	FDA UDI	Class II	Unknown
Cosmostar Longlife / 100w	F71 T12 100W PH / BiPin	FDA UDI	Class II	Active
Goldarium Sp / 100-120w	F73T12 / GOLDARIUM SP / 100-120W / RDC	FDA UDI	Class II	Active
Bronzing Sun Plus / 100w	BRONZING SUN PLUS BSP71-T12-100-120WR BI-PIN	FDA UDI	Class II	Active
Pro TECH	FR79T12 PRO TECH II ULTRA INTENSIVE RUVA 200W XL	FDA UDI	Class II	Active
Meridian Bronzer / 100w	FR71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
Golden Bronze / 100-120w	FR71 T12 100W PH / BiPin	FDA UDI	Class II	Unknown
Perfect Bronze	FR71T12 160W	FDA UDI	Class II	Unknown
Radiance 8.5 / 100-120w	F74 T12 100W PH / RDC	FDA UDI	Class II	Active
Radiance 8000 7.5 / 100-120w	F73 T12 100W RS / RDC	FDA UDI	Class II	Active
Meridian / 160w	F71 T12 160W VHO PH / BiPin	FDA UDI	Class II	Unknown
CosmoLux	FR2M T12 CosmoLux Lynx S5 200W	FDA UDI	Class II	Active
Cosmolux Vhr	FR79T12 COSMOLUX VHR 9K90 180-225W	FDA UDI	Class II	Active
Elite Ultra / 200w	FR79 T12 180W VHO PH / BiPin	FDA UDI	Class II	Unknown
Velocity Ultra / 180w	FR71 T12 160W VHO PH / BiPin	FDA UDI	Class II	Unknown
Inferno/P / 25w	F25 T5 25W PH / BiPin	FDA UDI	Class II	Unknown
Golden Bronze / 100-120w	FR71 T12 100W PH / BiPin	FDA UDI	Class II	Active
Master Bronze / 100-120w	F71 T12 100W PH / BiPin	FDA UDI	Class II	Active
Perfect Bronze	F71T12 100-120W 5.5	FDA UDI	Class II	Unknown
Radiance Black / 160w	FR71 T12 160W VHO PH / BiPin	FDA UDI	Class II	Active
Dark Tan Ii / 100w	F73 T12 100W RS / RDC	FDA UDI	Class II	Active
Original Sun / 140w / Sm	FR59 T12 140W HO PH / BiPin	FDA UDI	Class II	Unknown
Golden Sun Plus Ho Let 024.0204/ 100w	F73 T12 100W RS / RDC	FDA UDI	Class II	Unknown
Bronzing Sun / 160w	FR73 T12 160W VHO RS / RDC	FDA UDI	Class II	Unknown
Golden Bronze / 180-200w	FR79 T12 180W VHO PH / BiPin	FDA UDI	Class II	Unknown
Meridian Bronzer / 120w	F73 T12 100W RS / RDC	FDA UDI	Class II	Unknown
Suncapsule Vhr / 160w	FR71 T12 160W VHO PH / BiPin	FDA UDI	Class II	Unknown
GOLDEN BRONZE Plus / 100-120W	F71 T12 100W PH / BiPin	FDA UDI	Class II	Active

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