IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032)

The IPL Home Use Hair Removal Device is an over-the-counter, home-use device that removes unwanted hair using Intense Pulsed Light (IPL) technology. It is indicated for hair removal and permanent reduction in hair regrowth, defined as long-term stable reduction measured at 6, 9, and 12 months after treatment completion. The device works below the skin's surface without cutting or pulling, and includes five models (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032) with identical intended use but differences in appearance, dimensions, and light output parameters.

The subject device uses Intense Pulsed Light from a xenon arc flashlamp with wavelength range 550–1200 nm, energy density 2–7 J/cm², spot size 3.0–3.3 cm², and pulse duration 10 ms ± 2 ms. It has 5–9 output intensity levels, manual finger-switch activation, a skin-contact sensor, integrated cooling function, and is powered by external adapter (100–240V, 50/60 Hz). Minor differences from predicate include dimension variations and higher intensity level options (5–9 levels versus 5 levels).

Biocompatibility: ISO 10993-5, ISO 10993-10, ISO 10993-23. Electrical safety and EMC: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57. Eye safety: IEC 62471. Software: basic documentation level with system validation testing. Usability: FDA guidance on human factors and usability engineering to medical devices (February 2016).

The subject device has the same intended use, mode of action, and similar operational characteristics as the predicate device (Shenzhen Ulike IPL Home Use Hair Removal, K230122). Non-clinical testing demonstrates that the device is safe and effective as the predicate, and minor differences in dimensions and intensity levels do not raise safety or efficacy concerns. Performance data supports substantial equivalence to both the predicate and reference devices.