Red/infrared light phototherapy unit

Intended purpose

The AM LUXE LUMINA Light Therapy Mask is a reusable, non-invasive, Class IIa medical device intended for dermatological phototherapy using low-level light-emitting diode (LED) technology. The device is designed to deliver specific wavelengths of non-heating light energy to the facial skin to promote skin rejuvenation, assist in the management of mild to moderate acne, and reduce the visible signs of skin ageing. The mask incorporates four distinct wavelengths, each chosen for their clinically supported biological effects: Blue light (415 nm): Penetrates the superficial layers of the skin to target Cutibacterium acnes, aiding in the management of mild to moderate acne-prone skin. Red light (660 nm): Penetrates the dermal layer to stimulate fibroblast activity, supporting natural collagen and elastin production, thereby reducing the appearance of fine lines and wrinkles and improving skin firmness. Amber/Yellow light (590 nm): Enhances skin tone and radiance, promotes circulation, and assists in the temporary reduction of facial redness. Near-infrared light (850 nm): Penetrates deeply into the skin to reduce inflammation, support recovery, and enhance the effects of other wavelengths. The AM LUXE LUMINA mask is intended for repeated, non-sterile use in both professional skincare environments and at-home settings. It is designed to be user-friendly, with flexible silicone construction, automatic treatment timing, and safety controls to ensure consistent and effective delivery of light energy. The intended purposes of the device are to: Improve overall skin tone, texture, and radiance Reduce the visible signs of ageing, including fine lines and wrinkles Assist in the management of mild to moderate acne-prone skin Provide temporary relief of facial redness Promote general skin rejuvenation and support post-treatment recovery The device is not intended for the treatment of malignant lesions, skin cancers, or use on infants. It is supplied non-sterile with cleaning instructions provided in the Instructions for Use. This intended purpose aligns with GMDN code 65723 – Light-emitting diode dermatological therapy unit, non-heating.