IPL Hair Removal Device (MLY-M011); IPL Hair Removal Device (MLY-M012); IPL Hair Removal Device (MLY-M013); IPL Hair Removal Device (MLY-M015); IPL Hair Removal Device (MLY-T001); IPL Hair Removal Device (MLY-T002)

The IPL Hair Removal Device is an over-the-counter device for permanent reduction of unwanted body hair using intense pulsed light (IPL) technology. It is intended for use by adults with Fitzpatrick skin types I-IV and operates by emitting light pulses below the skin's surface without cutting or pulling, delivering treatment through direct illumination to tissue.

The device uses xenon arc flashlamp technology powered by external adapter (AC100-240V, DC12V output). It features 5 intensity levels, pulse duration of 8±2.0ms, energy density of 1.6-3.5J/cm², wavelength 530-1200nm, and irradiation areas ranging from 2.5-3.5cm² depending on model. Some models include cooling function; specifications vary slightly across six models (MLY-M011 through MLY-T002) but share identical intended use and performance.

IEC 60601-1:2005+A1:2012+A2:2020 (general requirements for medical electrical equipment), IEC 60601-1-2:2020 (electromagnetic compatibility), IEC 60601-1-11:2015+A1:2020 (home healthcare environment), IEC 60601-2-83:2019+A1:2022 (home light therapy equipment), IEC 62471:2006 (photobiological safety), ISO 10993-5:2009, ISO 10993-10:2021, and ISO 10993-23:2021 (biocompatibility testing).

The device has identical intended use, mode of action, and similar operational characteristics as predicate devices K231800 and K242595. Although specifications differ slightly (irradiation area, wavelength range, energy output, and pulse duration), the key safety and effectiveness parameter—energy density—falls within the predicate range. All devices comply with the same IEC 60601-2-83 standard for home light therapy equipment, and non-clinical testing confirms the subject device is as safe and effective as the predicates for hair removal.