LED Light Therapy Mask (RT01)

The LED Light Therapy Mask (RT01) is a wearable, over-the-counter phototherapy device that emits blue (415nm), red (630nm), and near-infrared (830nm) light to treat mild to moderate acne vulgaris and full-face wrinkles. Users wear the mask on their face for 10-minute treatment sessions, with the device controlled via a handheld controller containing a rechargeable lithium battery. The mask includes optional heating pads for the lower eyelids.

The subject device matches the predicate device in wavelengths (blue 415±10nm, red 630±10nm, NIR 830±10nm), light intensity (blue 28 mW/cm², red 16–18 mW/cm², NIR 11 mW/cm²), treatment duration (10 minutes), treatment dosing, and protocol (acne 4× weekly for 6 weeks; wrinkles 5× weekly for 6 weeks). The subject device differs only in battery capacity (3.7V/3800mAh versus 5V/9.62Wh) and includes an optional heating function for the lower eyelids not publicly disclosed for the predicate.

IEC 60601-1:2005+AMD1:2012+AMD2:2020 (medical electrical equipment safety), IEC 60601-1-2:2014+AMD1:2020 (electromagnetic compatibility), IEC 60601-1-11:2015+AMD1:2020 (home healthcare environments), IEC 60601-2-57:2011 (non-laser light source equipment), IEC 62471:2006 (photobiological safety), IEC 62133-2:2017 (lithium battery safety), and ISO 10993 biocompatibility standards (cytotoxicity, sensitization, irritation, acute systemic toxicity).

The device is substantially equivalent because it has identical intended use (OTC treatment of acne and wrinkles), identical classification (Class II, OLP/OHS under 21 CFR 878.4810), and identical technological characteristics in all critical performance parameters—wavelengths, intensities, treatment times, and dosing. Non-critical differences (battery capacity and optional heating function) do not raise new safety or effectiveness questions, as the heating area (lower eyelids) does not overlap the acne/wrinkle treatment area (full face), and both devices meet the same IEC electrical safety and photobiological standards.