Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)

The Ice Cooling IPL Hair Removal Device is an over-the-counter, home-use device that uses Intense Pulsed Light (IPL) technology to remove unwanted hair and achieve permanent reduction in hair regrowth measured at 6, 9, and 12 months after treatment. It features a sapphire treatment window, ice cooling function throughout use, and a skin sensor to ensure proper contact before emitting light pulses.

The device uses a xenon arc flashlamp emitting light at 550–1200 nm wavelength with energy density of 2.42–7.27 J/cm² (or 2.42–5.45 J/cm² for certain models), spot size of 3.3 cm², and pulse duration of 1.82–8.07 ms in multipulse mode. It is powered by an external 100–240V adapter, measures 179.0×58.2×37.2 mm, and offers 4 output intensity levels (or 3 levels for certain variants), matching predicate devices in these core specifications.

Biocompatibility testing per ISO 10993-5, 10993-10, and 10993-23; electrical safety and EMC per IEC 60601-1, 60601-1-2, 60601-1-11, 60601-2-57, and 60601-2-83; light safety per IEC 62471; software verification and validation per Basic Documentation Level; and usability per IEC 60601-1-6 and FDA human factors guidance (February 2016).

The device has identical intended use (removal of unwanted hair and permanent reduction in regrowth) and the same operational characteristics as three legally marketed predicate devices (K250194, K230122, K221002). Performance testing demonstrates equivalent safety and efficacy across all critical parameters: wavelength range, energy density, spot size, pulse duration, pulsing control, and intensity levels. Minor design differences (such as specific model variants with reduced energy ranges) do not raise new safety or efficacy issues and performance data supports equivalence to predicates.