GLOW POD - RED LIGHT AND NEAR IR THERAPY

Description of Event or Problem

THIS COMPANY IS MANUFACTURING AND ADVERTISING A RED-LIGHT THERAPY DEVICE WITH EXPLICIT MEDICAL AND THERAPEUTIC CLAIMS ON THEIR WEBSITE LISTING. UNDER BOTH U.S. AND EU REGULATORY FRAMEWORKS, SUCH CLAIMS CLASSIFY THE PRODUCT AS A MEDICAL DEVICE. THEY ARE ALSO CLAIMING THEY HAVE ACQUIRED A CE MARK. CLAIMS THIS COMPANY MAKES FALL UNDER MULTIPLE PRODUCT CODES INCLUDING OLI AND ILY. OLI REQUIRES A 10K CLEARANCE ON TOP OF REGISTRATION THE COMPANY CLAIMS CE COMPLIANCE TIED TO A PRODUCT WITH CLEAR MEDICAL CLAIMS YET DOES NOT SAY THEY ARE REGISTERED WITH FDA AND UPON DOING A DATABASE SEARCH, THEY CANNOT BE FOUND IN THE FDA SYSTEM AT ALL. THE CONTINUED USE OF MEDICAL CLAIMS IN THE ABSENCE OF FDA REGISTRATION OR CLEARANCE STRONGLY SUGGESTS THE DEVICE IS BEING MARKETED IN VIOLATION OF APPLICABLE MEDICAL DEVICE REGULATIONS. THIS RAISES CONCERNS ABOUT REGULATORY NON-COMPLIANCE AND THE DISSEMINATION OF UNSUPPORTED MEDICAL CLAIMS TO CONSUMERS. THEY ALSO HAVE A REVIEW ON THE WEBSITE SAYING THERE ARE OVERHEATING ISSUES THAT POSE A FIRE RISK. WEB LISTING: HTTPS://WWW.HEALIXINFRARED.COM/PRODUCTS/HEALIX-GLOW-LIGHT-POD DOCUMENTATION CAN BE ACCESSED HERE: HTTPS://DRIVE.GOOGLE.COM/DRIVE/FOLDERS/1QYP6UJRVYQWW-XWUA0WJJ34MPXJC6Z_S?USP=DRIVE_LINK.