IPL400

The Ice Cooling IPL Hair Removal Device is an over-the-counter home-use device for removing unwanted hair using Intense Pulsed Light (IPL) technology. It features a sapphire treatment window, skin contact sensor, ice cooling function, and can emit single, double, or triple pulses per shot. The device is indicated for hair removal and permanent reduction in hair regrowth measured at 6, 9, and 12 months after treatment completion.

The subject device uses a xenon arc flashlamp IPL source with wavelength range 550–1200 nm, energy density of 1.8–6.67 J/cm² (MI01 series) and 2.12–6.67 J/cm² (UI04S series), spot size 3–3.3 cm², and pulse duration 1.2–7.52 ms with variable single, double, or triple pulse modes. Minor differences from predicates include energy density and output energy within the range of predicate values, four intensity levels versus predicate's 1–10 levels, and dimension variations that do not affect function.

Testing compliance demonstrated with ISO 10993-5/10/23 (biocompatibility), IEC 60601-1/1-2/1-11/2-57/2-83 (electrical safety and performance), IEC 62471 (photobiological safety), IEC 60601-1-6 (usability), and software verification and validation per FDA guidance on human factors engineering.

The device is substantially equivalent because it has the same intended use (OTC hair removal and permanent reduction), same regulatory classification (Class II, product code OHT), same technology platform (IPL with xenon flashlamp), and overlapping operational specifications with predicates. Minor parameter differences (energy density, pulse width, intensity levels) fall within the ranges of predicate devices and all comply with applicable safety and performance standards, thus raising no new safety or efficacy concerns. Performance testing confirms the device operates as safely and effectively as legally marketed predicates.