Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM)

The Intense Pulsed Light (IPL) System is an over-the-counter device intended for removal of unwanted body hair. It uses a xenon arc flashlamp to deliver intense pulsed light energy below the skin's surface without cutting or pulling, with minimal pain. The device includes a touch chip to ensure proper skin contact before light emission and cooling care functions on select models to reduce heat during treatment.

The subject device uses a xenon arc lamp with wavelength range 560±20nm to 1200nm, output energy of 25–28J depending on model, energy density of 5.1–8.48 J/cm², pulse width of 0.4–12 ms, and spot sizes of 3.0–3.3 cm². It operates at 1–5 intensity levels with finger-switch pulsing control and microprocessor control. Operating environment is 5–26°C and 20–90% relative humidity; storage is –20 to –55°C.

Electrical safety and EMC: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83. Eye safety: IEC 62471. Biocompatibility: ISO 10993-5, ISO 10993-10, ISO 10993-23. Performance testing included energy output, fluence, and pulse duration verification.

The subject device has the same intended use, mode of action, and similar operational characteristics as its predicate device (K251173). The tissue-contacting materials are identical to the predicate, and surface-contacting materials (ABS and PC) are biocompatible per FDA guidance. All performance specifications (wavelength, energy, pulse width, spot size) and test results demonstrate the device is as safe and effective as the legally marketed predicate device.