CELLIANT is tested and proven to work with REPREVE, the global leader in recycled performance fibers. Leveraging its proprietary regeneration technology, REPREVE has transformed more than 35 billion plastic bottles into recycled fiber that delivers enhanced comfort, greater performance, and superior durability. As the only eco-performance fiber with U TRUST® product verification to certify transparency and traceability, REPREVE empowers brands and consumers to champion sustainability.
The CELLIANT Science Advisory Board works with primary investigators to rigorously test and validate the science of infrared and its benefits. This includes experts in photobiology, nanotechnology, sleep medicine, human physiology, diabetes, and wound care. To date, there have been 10 peer-reviewed published studies.
The FDA has determined that CELLIANT® products are medical devices as defined in section 201(h) of the Federal Food, Drug and Cosmetic Act and are general wellness products.
The FDA has not approved or designated CELLIANT® products for any purpose and has not made any determination about, or endorsement of, its stated use or benefits.
As part of the 513(g) submission process, the FDA reviewed and commented on appropriate health and wellness claims for CELLIANT products.
CELLIANT® is designated as a Class 1 Medical Device in Australia, Canada, the European Union, Japan, New Zealand, Switzerland, the United Arab Emirates and the United Kingdom. CELLIANT® is cleared to market in China, India, Indonesia, Korea, Malaysia, Mexico, Peru, Philippines, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand and Vietnam, with more countries and regions to follow.
For more information on the FDA classification of a medical device, visit the U.S. FDA site.
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