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

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 provide long-term stable reduction in hair regrowth measured at 6, 9, and 12 months post-treatment. The device features a sapphire treatment window, ice cooling function for user comfort, and a skin sensor that prevents light emission unless the device is in full contact with skin.

The subject device uses a xenon arc flashlamp with wavelength range 550–1200 nm, energy density 2.42–7.27 J/cm², output energy 8–24 J, spot size 3.3 cm², and multipulse duration of 1.82–8.07 ms at 4 energy levels. Minor differences from predicates include slightly different output energy (within predicate 1's range), pulse width (within predicate 3's range), and energy levels (4 vs. 5 or 1–10), but all parameters comply with IEC 60601-2-57/2-83 and IEC 62471 standards.

Biocompatibility 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; photobiological safety per IEC 62471; software verification per Basic Documentation Level; and usability per IEC 60601-1-6 and FDA human factors guidance.

The subject device has identical intended use, regulatory classification (Class II, OTC), and fundamental design (IPL-based hair removal) as three legally marketed Ulike predicates. All devices comply with the same safety and performance standards. Minor technical variations in dimension, energy density, output energy, pulse duration, and intensity levels are non-material and do not raise safety or effectiveness concerns because they remain within acceptable ranges or match predicate specifications, and all devices undergo equivalent biocompatibility, electrical, and optical safety testing.