IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16, FDA17, FDA18, FDA19, FDA20, FDA21S, FDA22S, FDA23S, FDA24S, FDA25, FDA26, FDA27, FDA28, FDA29S, FDA30S, FDA31S)

The IPL Home Use Hair Removal Device is an over-the-counter, handheld device for home use that removes unwanted body and facial hair using Intense Pulsed Light (IPL) technology. It operates below the skin's surface without cutting or pulling, and includes 21 models, some with cooling functions. The device is powered by an external adapter and includes a skin sensor to ensure proper contact before emitting treatment pulses.

The device uses a xenon lamp as the light source with a wavelength range of 510–1200 nm (±15 nm), energy density of 1.37–4.28 J/cm², spot size of 3.5 cm², and pulse duration of 3.5–4.5 ms (±0.9 ms). It features a finger-switch pulsing control and direct tissue illumination delivery. These characteristics are similar to the predicate devices, with minor variations in energy density ranges that do not raise safety or efficacy concerns.

Biocompatibility testing per ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), and ISO 10993-23 (irritation). Electrical safety and EMC testing per IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-83. Eye safety per IEC 62471. Software validation testing demonstrated compliance with software requirement specifications.

The subject device is substantially equivalent to its predicate devices because it has identical intended use (over-the-counter home hair removal), same regulatory classification (Class II under 21 CFR 878.4810), same fundamental technology (IPL with xenon lamp), and similar technological specifications (wavelength, energy density, spot size, pulse duration). Performance testing demonstrates the device is as safe and effective as the predicate devices for its intended use.