LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W)

The LED Light Therapy Mask is a wearable home-use phototherapy device that emits narrow-band light in four wavelengths: red (630±5nm and 660±5nm), infrared (850±5nm), amber (605±5nm), and blue (460±5nm). It is used for treating full-face wrinkles, inflammatory acne, arthritis, muscle spasm, and stiffness by providing topical heating and promoting blood circulation.

The device uses LEDs with similar wavelengths and comparable light intensities to the predicate device (ranging from 8–30 mW/cm² depending on mode and level). The subject device offers 10-minute treatment times with adjustable intensity levels, while the predicate offers manual (15 minutes) or automatic (10 minutes) modes. Both use AC 100-240V power inputs and employ rechargeable lithium batteries with similar electrical safety and biocompatibility standards.

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83, IEC 62471, IEC 62133-2; ISO 10993-5, ISO 10993-10, ISO 10993-23 for biocompatibility; FDA guidance on human factors and usability engineering.

The subject device is substantially equivalent because it uses the same LED light source technology with similar wavelengths and power outputs, identical regulatory classification and product codes as the predicate, the same indications for use, and equivalent electrical safety, biocompatibility, and eye safety performance. Both are OTC wearable masks designed for facial treatment with comparable technological characteristics and performance data.