Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025)

The Hair Removal Device is an over-the-counter, home-use device that uses Intense Pulsed Light (IPL) technology 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 ice-cooling or sapphire ice-cooling functions depending on the model. Eighteen models are covered in this submission (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017, DT017 Pro, DT025 Pro, DT025).

The devices use Intense Pulsed Light with wavelengths from 560–1200 nm (depending on model), powered by external AC 100–240V adapters. Spot sizes range from 3.0 cm² to 4.2 cm² depending on model; energy densities vary from 2–5.7 J/cm²; and pulse durations range from 0.86–15 ms. All models incorporate finger-switch control, microprocessor control, and safety features including skin contact sensors. Models differ in dimensions, cooling mechanisms (ice or sapphire), and output intensity levels (5–9 levels), but share the same IPL technology and mode of action.

Biocompatibility testing per ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-23. Electrical safety and EMC per IEC 60601-1, IEC 60601-1-2:2014+A1:2020, IEC 60601-1-11:2015, and IEC 60601-2-83:2019. Eye safety per IEC 62471:2006. Software verification and validation per FDA guidance on human factors and usability engineering (February 2016).

The subject devices are substantially equivalent to their respective predicate devices because they share the same intended use (removal of unwanted hair and permanent reduction in hair regrowth), same mode of action (IPL technology), same regulatory classification (Class II), and comparable technological characteristics. Performance data demonstrates the devices are as safe and effective as the predicates. Minor design differences (e.g., dimensions, energy density ranges, cooling mechanisms) do not raise safety or efficacy concerns and are consistent with existing cleared IPL hair removal devices.