GLAM LED Facial Mask (TB-2386F)

The GLAM LED Facial Mask is a wearable light-emitting diode phototherapy device that produces red, blue, and yellow light for home use. Red light treats full-face wrinkles, blue light treats mild to moderate inflammatory acne, and yellow light treats wrinkles. The device is worn as a mask with an automatic 15-minute cycle timer and includes eye protection.

The device uses LED diodes mounted behind a clear polycarbonate shell to generate blue (415nm ±10nm), yellow (590nm ±10nm), and red (625nm ±10nm) wavelengths. Key differences from predicates include varying power density and treatment time, though the resulting standard dose in Joules remains comparable and falls within acceptable deviation ranges per IEC 60601-2-57 testing.

IEC 60601-1:2005+AMD1:2012+AMD2:2020, IEC 60601-1-2:2014, IEC TR 60601-4-2:2016, IEC 60601-1-11:2020, IEC 60601-2-57:2011-01, IEC 60601-2-83:2023, ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021, IEC 62471:2006, and IEC 62304:2006.

The subject device and predicates (TheraFace Mask, Radiant Renewal Skincare Lid) are all Class II laser surgical instruments sharing the same product codes and indications for use. Although power density and treatment time differ between subject and predicates, the resulting standard dose is comparable and falls within acceptable deviation ranges validated by IEC 60601-2-57 testing. Non-clinical testing confirms biocompatibility and electrical safety compliance, and no animal or clinical studies identified safety or effectiveness concerns, demonstrating technical and functional equivalence.