Ulike Reglow Light Therapy Device (UM10)

The Ulike Reglow Light Therapy Device (UM10) is an over-the-counter LED-based mask containing 272 light-emitting diodes that emit multiple wavelengths (630nm, 830nm, 590nm, and 465nm) to treat full-face wrinkles and mild to moderate inflammatory acne. Users place the mask over their face and operate it via an external controller with four selectable treatment modes, each lasting 5-8 minutes.

The device uses 272 LEDs with four selectable operating modes delivering wavelengths of 630nm±10nm, 830nm±10nm, 590nm±10nm, and 465nm±10nm at 1-40mW/cm² intensity. It is powered by a 3.7V, 2600mAh lithium battery (9.62Wh) in the controller and includes a protective eye-shield to block light from the eyes. Minor modifications include new component suppliers (battery and LED suppliers with identical specifications) and packaging changes (Type-C charging cable instead of adapter).

IEC 62133-2:2017+2021 (lithium battery safety), IEC 62471:2006 (photobiological safety), IEC 60601-1:2005+A1:2012+A2:2020 (medical electrical equipment general safety), IEC 60601-2-57:2011 (non-laser therapeutic equipment safety), and IEC 60601-2-83:2019 (home light therapy equipment safety). Biocompatibility testing per ISO 10993-5, ISO 10993-10, and ISO 10993-23.

The subject device is substantially equivalent to its predicate (K243492) because it has identical intended use, indications, prescription status (OTC), intended location of use (face), light source (LED), wavelengths, LED intensity, treatment times, electrical and eye safety standards, and biocompatibility testing. The minor modifications (alternative suppliers with same specifications and packaging changes) do not raise any safety or efficacy concerns and are supported by performance testing.