Ulike Reglow Light Therapy Device (UM10)

The Ulike Reglow Light Therapy Device (UM10) is an over-the-counter LED light therapy mask intended for treatment of full-face wrinkles and mild to moderate inflammatory acne. It uses light-emitting diodes at wavelengths of 465nm, 590nm, 630nm, and 830nm, with a protective eye-shield to block light from the eyes during treatment.

The device uses LED light sources (not lasers) at four specific wavelengths, compared to predicate devices using similar or overlapping wavelengths. It delivers 1-40 mW/cm² intensity, has a lithium battery power supply (3.7V, 2600mAh), and incorporates a mask form factor with a separate handheld controller. Minor differences include slightly different wavelength specifications and power levels compared to predicate devices, but all fall within safe and effective ranges demonstrated by testing.

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, IEC 60601-2-83, IEC 62471, IEC 62133-2, ISO 10993-5, ISO 10993-10, and ISO 10993-23. Testing demonstrated biocompatibility, electrical safety, electromagnetic compatibility, photobiological safety, and usability compliance.

The subject device shares the same intended use (wrinkle and acne treatment via LED light therapy) and similar operational characteristics as legally marketed predicates. Although minor differences exist in wavelength specifications, LED intensity, and power supply details, these fall within the functional ranges of predicate devices and do not raise new safety or efficacy issues. Comprehensive testing to IEC and ISO standards—including biocompatibility, electrical safety, and light safety—demonstrates the device performs equivalently to predicates, supporting substantial equivalence.