IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G)

The 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. The device works below the skin's surface without cutting or pulling, and includes a skin sensor, cooling function, and finger-switch activation powered by an external adapter.

The device uses a xenon flashlamp to emit IPL in the 510–1200 nm wavelength range with an energy density of 1.2–3.0 J/cm², output energy of 5–9 J, 3.0 cm² spot size, and pulse duration of 9.3±1.86 ms. It has three intensity levels and is controlled by finger switch. Key differences from the predicate include smaller dimensions, fewer intensity levels (3 versus 6–9), and similar but not identical pulse duration.

Biocompatibility testing per ISO 10993-5 and 10993-10; electrical safety per IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-83; electromagnetic compatibility per IEC 60601-1-2:2014+A1:2020; eye safety per IEC 62471:2006; and software verification and validation at moderate level of concern.

The subject device is substantially equivalent because it has identical intended use (removal of unwanted hair and permanent reduction in hair regrowth measured at 6, 9, and 12 months), the same mode of action (IPL-based hair removal), and similar operational characteristics including wavelength range, energy density, output energy, spot size, and pulse duration to both the predicate and reference devices. Minor differences in device dimensions and intensity level count do not raise safety or efficacy concerns and performance data demonstrates the device is as safe and effective as the predicate.