LED Facial Mask

The LED Facial Mask is an over-the-counter device that emits light in red, blue, and near-infrared wavelengths from LEDs housed in a mask-like form factor. It is intended for treating full-face wrinkles (red modes), mild to moderate acne (blue mode), and providing topical heating for temporary pain relief and improved circulation (NIR mode).

The device uses LED light sources emitting blue (410/460 nm), red (610/630/660 nm), and NIR (830/850/880 nm) wavelengths at irradiances ranging from 6.1 to 81.0 mW/cm² depending on mode. Treatment duration is 5 minutes per session, 3 days per week. The device includes a controller, fastening straps, and rechargeable battery; wavelengths and irradiance levels fall within the ranges of predicate devices despite differences in LED count and specific intensity values.

IEC 60601-1:2005+AMD1:2012+AMD2:2020 (medical electrical equipment general safety); IEC 60601-1-2:2014+AMD1:2020 (electromagnetic disturbances); IEC 60601-2-57:2023 (non-laser light source equipment); IEC 60601-2-83:2019+AMD1:2022 (home light therapy equipment); ISO 10993 series (biocompatibility); IEC 62471:2006 (photobiological safety); IEC 62304:2006+AMD1:2015 (software lifecycle).

The proposed device shares the same anatomical location (face), intended uses (wrinkle treatment, acne treatment, topical heating), light source type (LED), OTC classification, and product codes (OHS, ILY, OLP) as the predicate device K223544. Although the proposed device exhibits minor differences in LED count, specific wavelength combinations, and irradiance values, the total accumulated treatment energy remains within the range established by multiple predicate and reference devices. These minor design variations do not raise safety or efficacy concerns because similar devices with varying LED quantities and irradiance levels have been successfully cleared under the same regulatory classification.