IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)

The IPL Hair Removal Device (models HCT-1208/HCT-1208B/HCT-1208L) is an over-the-counter, light-based hair reduction device using Intense Pulsed Light (IPL) technology. It is intended for removal of unwanted body hair on large areas (arms, legs, chest) and small areas (lips) and is powered by an external adapter with finger-switch activation.

The device uses a Xenon arc lamp with wavelength range 530–1200 nm, energy density 2.08–4.58 J/cm², output energy 5.0–11.0 J, spot size 2.4 cm², pulse duration 6.0–8.0 ms, and five output energy levels. It includes a built-in skin sensor to detect appropriate skin contact. Three models differ slightly in physical dimensions and materials (HCT-1208L uses sapphire treatment window; HCT-1208B and HCT-1208 use glass), but share the same work principle and intended use.

ISO 10993-5 (in vitro cytotoxicity), ISO 10993-10 (skin sensitization), ISO 10993-23 (skin irritation); IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83 (electrical safety and EMC); IEC 62471 (photobiological safety).

The subject device has identical intended use, mode of action (IPL-based hair reduction), and similar operational characteristics (finger-switch control, five output levels, skin sensor) as the predicate device (K242595, IPL-18 BF/FG). Minor differences in wavelength range, energy density, pulse duration, and materials do not raise safety or efficacy concerns because the device complies with the same IEC standards as the predicate. Performance testing confirms safety and effectiveness equivalent to the predicate, and biocompatibility and electrical safety testing passed applicable ISO and IEC standards.