Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF)

The Intense Pulsed Light (IPL) System is an over-the-counter device for removal of unwanted body hair using intense pulsed light technology. It works below the skin's surface without cutting or pulling, reducing hair growth with minimal pain. The device is powered by an adapter and controlled via a finger switch or automatic light emission.

The device uses a Xenon arc flashlamp with wavelength range 560±20nm to ~1200nm, maximum output energy of 16.7–17.2J depending on model, and energy density of 4.2–5.4J/cm². It features a touch chip for skin contact detection, adjustable intensity levels (1–5), pulse duration of 0.4–12ms, and a 3.3–4.0cm² spot size. Selected models include cooling care functions, dual pulse technology, or skin color sensors for enhanced safety.

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83 (electrical safety and EMC); IEC 62471 (eye safety); ISO 10993-5, ISO 10993-10, ISO 10993-23 (biocompatibility).

The subject device has identical intended use (over-the-counter hair removal), the same mode of action (intense pulsed light), and similar operational specifications as the predicate device K221569. All key performance parameters—wavelength range, output energy, energy density, pulse duration, and intensity levels—are within the same ranges as the predicate and reference devices. Biocompatibility, electrical safety, EMC, and eye safety testing all meet the same consensus standards and specifications, demonstrating equivalent safety and effectiveness profiles.