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Talk to a SpecialistTalk to a SpecialistInvisi Smart Technologies UK LTD marketed face masks (ISM5 and ISM30 models) with unapproved disease claims related to COVID-19 mitigation and prevention, including statements that the masks killed viruses, were self-disinfecting, and had been tested against SARS-CoV-2. The company sold these products in the United States without FDA marketing approval, clearance, or authorization, making them adulterated medical devices under the Federal Food, Drug, and Cosmetic Act. The violations centered on making therapeutic claims about coronavirus prevention and treatment without the required regulatory authorization and promoting unsubstantiated antimicrobial efficacy based on titanium dioxide content.