LED Light Therapy Mask (Models: T2, RLD10)

The LED Light Therapy Mask (Models T2, RLD10) is a wearable, home-use phototherapy device that emits red light (630nm), blue light (470nm), and infrared light (850nm) to treat full-face wrinkles and mild to moderate inflammatory acne. The device consists of a mask with integrated LEDs, a controller, charging cable, and safety goggles.

The device uses Light Emitting Diodes (LEDs) at wavelengths of 630nm ±10nm (red), 850nm ±10nm (infrared), and 470±10nm (blue). It operates at variable power levels (30–70 mW/cm² depending on mode), offers treatment times of 10, 20, or 30 minutes, and is powered by a rechargeable lithium battery (5V, 1A output). Materials include ABS enclosure and silicone mask with intact skin contact over >24 hours but ≤30 days.

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83, IEC 62471 (photobiological safety), and IEC 62133-2 (lithium battery safety). The device also underwent software verification and validation per FDA guidance on device software functions.

The subject device is substantially equivalent to predicate K241857 and reference devices K230351, K242151, K250830, and K242796 because it shares the same intended use (wrinkle and acne treatment via LED light), the same treatment wavelengths (630nm, 850nm, 470nm), similar technological principles (LED phototherapy), comparable power densities, and compliance with the same regulatory classification (Class II, 21 CFR 878.4810). Minor differences in power supply design and dimensions do not raise safety or effectiveness concerns.