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As part of the 513(g) submission process, the FDA reviewed and commented on appropriate health and wellness claims for CELLIANT® products.

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.

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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