Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP)

The Ice Cooling IPL Hair Removal Device is an over-the-counter home-use device that uses Intense Pulsed Light (IPL) to remove unwanted hair and achieve permanent reduction in hair regrowth (measured at 6, 9, and 12 months post-treatment). It features dual lamps, a sapphire treatment window, skin contact detection, and ice cooling throughout use for comfort.

The device uses xenon arc flashlamp technology in the 550–1200 nm wavelength range with energy density of 1.67–6.67 J/cm², operates on multipulse mode with pulse durations of 0.88–3.20 ms, has a 3.9 cm² spot size, and provides 1–10 intensity levels controlled by finger switch. It is powered externally (100–240V, 50/60Hz) and includes software/firmware control with skin tone recognition capability on UI20S series models.

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, IEC 60601-2-83, IEC 62471, ISO 10993-5, ISO 10993-10, ISO 10993-23, and IEC 60601-1-6 (usability). Software verification and validation were performed per Basic Documentation Level standards.

The subject device has the same intended use (unwanted hair removal and permanent hair reduction) and comparable operational design as five predicate devices. Minor differences in dimension, wavelength, energy density, output energy, spot size, pulse duration, and intensity levels are not safety or effectiveness concerns because: (1) they fall within the ranges of predicate device specifications, (2) all devices comply with the same electrical safety and photobiological standards, and (3) the subject device's performance data (biocompatibility, electrical safety, eye safety, and usability testing) demonstrate equivalence to legally marketed predicates.