Ultrasun achieved official FDA registration for nine models of sunbeds
We are very happy to announce that Ultrasun achieved official FDA registration for nine models of sunbeds. After several years without new tanning devices on the North American market, nine different Ultrasun devices have been officially FDA approved and registered for sale on the North American market.
Whereas in Europe, tanning devices must comply with the so-called 0.3 W/m2 and/or UV3 legislation with softer lamps and less output than the sun on a summer’s day, the rules in the United States are different. Tanning devices in the USA are considered medical and must therefore be certified according to the applicable quality standards (including ISO 13485). Here, less attention is paid to UV output, though many safety aspects in relation to components, electronics, production/assembly, and the overall quality management system are of high importance. All tests and certifications have been successfully conducted at Intertek in California (USA) with support from FDA consultants. These consultants used the test reports to successfully register the equipment with the FDA. In addition, Ultrasun has chosen to record its quality management system using an online software system officially recognized by the FDA: GreenLight Guru.
Which sunbeds have been approved by the FDA?
Ultrasun has succeeded in obtaining approval for a wide range of tanning equipment. This concerns both horizontal and vertical machines:
- Ultrasun Q6-0 with 32 lamps
- Ultrasun Q6-2 with 32 lamps and 2 facial tanners
- Ultrasun Q10 with 38 lamps and 3 facial tanners
- Ultrasun Q14 with 40 lamps and 3 facial tanners
- Ultrasun Q18 with 45 lamps and 4 facial tanners
- Ultrasun Q22 with 52 lamps and 4 facial tanners
- Ultrasun E6 with 42 lamps
- Ultrasun i8 with 48 lamps
- Ultrasun i9 with 64 lamps
Options such as air-conditioning, aroma/breeze system, audio system, and VibraPlate (only available for Ultrasun i8 and i9) have also been approved.
The registration also includes a previously achieved certification: The extensive range of Sunfit lamps, which are widely used in North America. This also guarantees that we can serve the replacement market with our original Sunfit lamps.
Where can I buy my FDA-approved equipment?
Ultrasun, Sunfit, and other related products are exclusively available through Tanning Supplies Unlimited in North America. Tanning Supplies Unlimited has been a very loyal Ultrasun partner for almost 25 years. For more information also visit their website.
Because Ultrasun achieved the official FDA registration, exporting equipment to countries such as Saudi Arabia, Brazil and Thailand will become much easier. These countries recognize the tests/inspections carried out at Intertek and the FDA registration is also accepted by their local authorities.
For further questions about the legislation and approvement, please do not hesitate to contact us.