The GlowRegen™ LED Mask is intended for cosmetic use only. It is not a medical device and has not yet been evaluated, approved, or certified by the U.S. Food and Drug Administration (FDA), the European Union (EU) regulatory authorities, Health Canada, the Australian Therapeutic Goods Administration (TGA), or any other regulatory body worldwide. We are currently in the process of seeking applicable regulatory approvals. This product is not designed to diagnose, treat, cure, or prevent any disease or medical condition. It is intended solely to support the appearance of healthier, more radiant skin as part of your skincare routine. Individual results may vary.