MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10)

The MEGELIN LED Light Therapy Mask is an over-the-counter wearable device that uses red light (660±20nm) to treat full-face wrinkles and blue light (460±20nm) to treat mild to moderate inflammatory acne. It is available in multiple models (JML1–JML10) that serve as face or neck masks with varying energy density settings. The device is operated by placing it on the skin for 10–20 minutes per session and can be used by consumers aged 18 or older or by professional personnel.

The subject device uses LED light at wavelengths of 660nm (red) and 460nm (blue), with intensity settings ranging from 10–55 mW/cm² depending on model. It features a rechargeable lithium-ion battery with over 1000 hours of operational life and a 5-year product lifespan. The device is composed of silica gel, ABS, and polyurethane fiber materials and includes software/firmware microprocessor control for treatment timing and modes.

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83, IEC 62471, IEC 62133-2 (electrical safety and photobiological safety); ISO 10993-5, ISO 10993-10, ISO 10993-23 (biocompatibility including cytotoxicity, sensitization, and irritation).

The MEGELIN mask is substantially equivalent to its predicates because it has identical intended use (OTC wrinkle reduction and acne treatment via red and blue LED light), the same regulatory classification (Class II, 21 CFR 878.4810), and similar technological characteristics. Minor differences in intensity ranges and wavelength tolerances fall within acceptable ranges of existing predicates and comply with relevant safety standards. All differences are considered non-material because they do not raise new safety or effectiveness concerns.