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

The Ice Cooling IPL Hair Removal Device is an over-the-counter home-use device that uses intense pulsed light (IPL) with a sapphire treatment window to remove unwanted hair and achieve long-lasting reduction in hair regrowth measured at 6, 9, and 12 months after treatment. It features dual lamps, a skin sensor for contact detection, and ice cooling throughout treatment for user comfort.

The device uses xenon arc flashlamp IPL at 550-1200nm wavelength with energy density of 1.65-6.92 J/cm², spot size 3.9cm², and variable pulse duration of 0.88-6.35ms with double and quadruple pulse modes. It is powered by external 100-240V adapter, controlled by finger switch, and includes 1-10 adjustable intensity levels with software control and skin pigmentation sensor.

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; AAMI ST98-2022, ASTM F3208-20, AAMI TIR12:2020; and software verification and validation per basic documentation level.

The device has the same intended use and similar operational characteristics as its predicates (K250942 and K130315), with identical regulation classification, product code, treatment areas, and fundamental IPL-based technology. Minor differences in pulse width and multipulse operation fall within predicate ranges and comply with applicable safety standards, supported by comprehensive biocompatibility, electrical safety, eye safety, and usability testing demonstrating equivalence in safety and effectiveness.