LED LIGHT MASK (A093)

The LED LIGHT MASK (A093) is an over-the-counter wearable mask device containing 64 LEDs that emit red (635nm), blue (425nm), or combined red-blue light to treat full-face wrinkles and mild to moderate inflammatory acne in adults at home. Users place the mask over their face and control it with a wired controller; the device automatically turns off after treatment and includes an integrated eye mask to block light from reaching the eyes.

The device uses LED light sources (rather than lasers) in red, blue, and red-blue modes with specified wavelengths and power outputs (red 1.98 mW/cm², blue 3.72 mW/cm², red-blue 1.24 mW/cm²). It is powered by a rechargeable lithium-ion battery (3.7V-2500mAh) and operates as an over-the-counter device for home use. The mask design measures 225×192×76mm with a separate wired controller, and treatment is recommended 3–5 times weekly for no more than 30 minutes continuously.

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, IEC 62471, IEC 62133-2; ISO 10993-5, ISO 10993-10, and ISO 10993-23 for biocompatibility; ANSI AAMI ES60601-1:2005/(R)2012 for electrical safety.

The subject device's indications for use (red light for wrinkles, blue light for acne, red-blue light for acne) are a subset of the predicate device's broader indications and fall within the predicate's technological scope. Although wavelengths and power levels differ numerically (e.g., red 635nm vs. 620nm, different mW/cm² values), both are within acceptable ranges and verified by FDA-recognized standards (IEC 60601-2-57 and IEC 62471), ensuring equivalent safety. The subject device omits infrared treatment modes present in the predicate but does not introduce new safety or effectiveness concerns; rather, it represents a narrower, simpler version of the same mask-based LED therapy class. Both devices use identical light sources (LEDs), biocompatible materials, similar power supplies, and equivalent electrical safety standards.