Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN)

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 a sapphire treatment window, skin sensor for contact detection, ice cooling function for comfort, and is powered by an external adapter with finger-switch activation.

The device emits single, double, or triple pulses per shot with wavelengths of 550–1200 nm, energy density of 1.8–6.67 J/cm² (depending on mode), output energy of 5.4–22 J, and pulse durations of 1.2–7.52 ms. It has 4 energy intensity levels, a 3–3.3 cm² spot size, and complies with IEC 60601-1, IEC 60601-2-57/2-83, and IEC 62471. Minor differences in dimensions, energy density, output energy, and pulse width exist versus predicates but fall within predicate ranges and do not raise safety concerns.

ISO 10993-5, 10993-10, 10993-23 (biocompatibility); IEC 60601-1, 60601-1-2, 60601-1-11, 60601-2-57, 60601-2-83 (electrical safety and EMC); IEC 62471 (photobiological safety); IEC 60601-1-6 (usability).

The subject device has identical intended use, regulatory classification (Class II, OTC), product code (OHT), and operational principle (IPL-based hair removal) as three legally marketed predicate devices. All minor technical differences—dimensions, energy density, output energy, pulse width, and intensity levels—either fall within predicate ranges or comply with the same applicable standards (IEC 60601-2-57/2-83, IEC 62471), demonstrating that such variations do not raise new safety or efficacy issues. Comprehensive biocompatibility, electrical safety, EMC, light safety, software, and usability testing confirm performance parity with predicates.