IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22, BHRL-23, BHRL-24, BHRL-25, BHRL-26, BHRL-27, BHRL-28, BHRL-29)

The IPL Hair Removal Device is an over-the-counter, home-use device that uses Intense Pulsed Light (IPL) technology to remove unwanted hair and provide permanent reduction in hair regrowth, measured at 6, 9, and 12 months after treatment completion. The device operates via finger-switch activation and includes a skin sensor to detect proper skin contact; most models also include a cooling function.

The subject device uses a xenon arc lamp IPL source with wavelength range 510–1200±15 nm, energy density 1.2–4.1 J/cm², output energy 4.5–10 J (±20%), and spot sizes of either 3.6±0.25 cm² or 2.7±0.25 cm² depending on model. It incorporates microprocessor control, operates on 100–240V 50/60Hz power, and requires no sterilization. Key differences from the predicate include varied dimensions across 23 models and a 5-level intensity control.

Biocompatibility per ISO 10993-1; 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 verification and validation per basic documentation level; usability per FDA's February 2016 guidance on human factors.

The device shares identical intended use (unwanted hair removal and permanent reduction in regrowth), same light-based mechanism of action (IPL technology), identical light source (xenon arc lamp), same general wavelength range, similar energy density and output parameters, and equivalent safety standards (electrical, optical, biocompatibility) with the legally-marketed predicate device K230739. Minor dimensional and control-level variations do not raise safety or efficacy concerns given substantially similar technical performance and non-clinical test results demonstrating equivalent safety and effectiveness.