Mirabella Phototherapy 7-Color LED Facial Mask with Infrared

The Mirabella Phototherapy 7-Color LED Facial Mask with Infrared does not appear to be FDA-cleared for medical use, as of the latest available information. While LED masks for facial treatments (such as those for acne, anti-aging, and skin rejuvenation) are often marketed as beauty devices, the FDA regulates them differently depending on their intended use. FDA Clearance: To be FDA-cleared, a device must go through a rigorous process that ensures it is safe and effective for its intended purpose. LED masks designed for general cosmetic purposes, like improving skin appearance or treating mild skin issues, may not always need FDA clearance, but if a device claims to treat specific medical conditions (such as acne or other dermatological disorders), it would typically require FDA clearance. Cosmetic Use: Many at-home LED masks are marketed as cosmetic devices and are therefore not subject to the same FDA approval as medical devices. However, they may still be registered with the FDA, which is a process that allows the FDA to keep track of devices sold to the public. This does not mean they are FDA-cleared for medical treatments. If you're considering purchasing this mask and are concerned about FDA clearance, it’s important to check the product details from the manufacturer or the retailer to confirm whether it’s FDA-registered, or whether it has any FDA-related certification. You can also inquire directly with the brand to get the most accurate information.

Hello. Thank you for your inquiry. Yes, the Mirabella Phototherapy 7-Color LED Facial Mask with Infrared is designed to emit infrared light simultaneously with the selected colored LED light.