Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK)

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 after treatment. It features dual lamps, a sapphire treatment window, skin contact sensors, and ice cooling throughout the treatment process for user comfort.

The device uses xenon arc flashlamp technology with wavelengths of 550–1200 nm, energy density of 1.65–6.92 J/cm², adjustable output intensity (1–10 levels), pulse durations of 0.86–6.32 ms in multipulse modes, and a 3.9 cm² spot size. It operates via external power adapter (100–240V, 50/60 Hz) with finger-switch activation and includes a skin pigmentation sensor for detecting appropriate skin contact.

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, IEC 60601-1-6, and FDA guidance on applying human factors and usability engineering to medical devices.

The subject device shares the same intended use (hair removal and permanent hair reduction) and fundamental operational design (IPL, xenon arc flashlamp, external power, finger-switch control, direct tissue illumination) as multiple legally marketed predicate devices. Although minor differences exist in energy density, output energy, and pulse duration parameters, these fall within the ranges of predicates and all devices comply with the same safety and efficacy standards (IEC 60601-2-83, IEC 62471). Performance testing—including biocompatibility, electrical safety, EMC, eye safety, software validation, and usability—demonstrates the subject device is safe and effective as the predicates for its intended use.