IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F)

The IPL Hair Removal device is an over-the-counter, light-based hair reduction system using Intense Pulsed Light (IPL) technology. It is intended for removal of unwanted body and/or facial hair and operates via finger-switch activation with a skin contact sensor that prevents emission if not properly applied to the treatment area.

The device uses a Xenon arc flashlamp with wavelengths of 530-1200nm, spot sizes ranging from 1.8cm² to 4.2cm² depending on model, pulse durations of 0.7-12ms, and energy densities of 1.6-6.1J/cm². Models differ in power adapters (12V-24V), button configurations, and included accessories, but all employ the same direct illumination delivery mechanism without requiring sterilization.

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83, IEC 62471, IEC 60601-1-6 for electrical safety and electromagnetic compatibility; software verification and validation per FDA guidance for Basic Documentation Level.

The subject device is substantially equivalent to predicate K242710 because it shares the same design principle, intended use, indications, product code (OHT), regulatory class (II), and applicable standards. Minor differences in spot size, pulse duration, and energy density fall within pre-validated safe and effective parameter ranges and do not raise new safety or effectiveness questions.