LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073)

The LED Light Therapy Mask is a wearable home-use phototherapy device consisting of a mask unit, controller, and charging cable. It emits red (630nm), blue (465nm), and infrared (850nm) light in five treatment modes to reduce full-face wrinkles, provide topical heating for arthritis and muscle relaxation, and treat mild to moderate inflammatory acne in adults.

The subject device has similar wavelengths (red 620nm, blue 465nm, infrared 850nm) and irradiance levels to the predicate device, with comparable power supply (5V 1A rechargeable lithium battery), light sources (LEDs), treatment times (10 minutes per session, 3-4 times weekly), and five distinct light mode outputs. Minor differences in irradiance and dimensions are noted but claimed insignificant.

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, skin sensitization, and irritation); FDA software verification and validation requirements.

The LED Light Therapy Mask is substantially equivalent to its predicate device (K243423) because it has identical intended use, same regulatory classification (Class II), matching product codes (OHS, OLP, ILY), and comparable technological characteristics including wavelength, irradiance, and power delivery. Minor differences in wavelength and irradiance fall within the range of predicate and reference devices and do not raise safety or efficacy concerns, and all devices comply with the same standards.