Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)

The Hand-held Hair Removal Device is an over-the-counter, home-use device that removes unwanted hair using Intense Pulsed Light (IPL) technology. It works below the skin's surface without cutting or pulling, and is indicated for hair removal and permanent reduction in hair regrowth measured at 6, 9, and 12 months post-treatment. The device covers a 3.0 cm² area and is suitable for multiple body areas including face, underarms, legs, bikini area, and back.

The subject device uses the same IPL technology, xenon arc lamp energy medium, and 590–1200 nm wavelength range as the predicate, with similar energy density (2–4.3 J/cm²), spot size (3 cm²), and finger-switch activation. Minor differences include pulse duration (2–6 ms vs. 0.5–0.8 ms in predicate), output intensity levels (9 levels matching predicate), and addition of a cooling function in some models. Device dimensions vary across eight models but fall within comparable ranges to predicate devices.

Biocompatibility (ISO 10993-1, ISO 10993-5, ISO 10993-10); Electrical Safety and EMC (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83); Eye Safety (IEC 62471); Software (basic documentation level with validation testing); Usability (FDA Applying Human Factors and Usability Engineering guidance, February 2016).

The device shares the same intended use (hair removal with permanent reduction), mode of action (IPL-based), and regulatory classification (Class II, OHT product code) as the predicate device K230739. Performance data demonstrates equivalent energy parameters and operational characteristics within the range of legally marketed predicate and reference devices. The addition of a cooling function and minor variations in dimensions and pulse duration do not raise new safety or efficacy issues, as the device is designed for the same home-use, over-the-counter application with equivalent skin contact materials (PC, ABS, POM) and contact duration (<24 hours).