IPL Hair Removal Device (KCA511/KCA516/KCA522)

The IPL Hair Removal Device (models KCA511, KCA516, KCA522) is an over-the-counter, home-use device that removes unwanted hair using intense pulsed light (IPL) energy. It is indicated for hair removal and permanent reduction in hair regrowth, defined as long-term stable reduction in regrowing hairs measured at 6, 9, and 12 months after treatment completion. The device features a 3.3 cm² treatment window, built-in skin sensor for contact detection, cooling function, and finger-switch activation powered by external adapter.

The subject device uses IPL at 610–1200 nm (±15 nm) with energy density of 2.18–7.27 J/cm² and output energy of 9–20 J (±20%), similar to the predicate. Key differences include pulse duration of 0.45 ms ± 0.2 ms (versus 8–12 ms for predicate) and power supply specifications (24V output versus 12V). Both devices have identical 3.3 cm² spot size, 5 intensity levels, software control, and require the same biocompatibility and electrical safety standards.

Biocompatibility per ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and sensitization), and ISO 10993-23 (irritation). Electrical safety and EMC per IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-83. Eye safety per IEC 62471. Software validation per moderate-level concern protocols.

The device shares identical intended use, mode of action (IPL-based hair reduction), and output specifications (wavelength, energy density, spot size, intensity levels) as the predicate. Differences in pulse duration and power supply specifications are minor and do not affect safety or efficacy because the energy delivered to tissue and wavelength characteristics remain substantially similar. Biocompatibility, electrical safety, and eye safety testing all meet the same standards as the predicate, and performance data demonstrate comparable safety and effectiveness profiles for the intended OTC home-use application.