IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C)

The IPL Hair Removal Device is an over-the-counter personal light-based hair reduction device using Intense Pulsed Light technology, with optional cooling functionality via Peltier effect semiconductor cooling. It is indicated for removal of unwanted hair on small areas (underarm, facial hair below chin) and large areas (legs), and for permanent reduction in hair regrowth measured at 6, 9, and 12 months post-treatment.

The device emits light at 510–1200 nm wavelength via Xenon arc flashlamp with 0.4–5.5 ms pulse duration, maximum fluence of 5.90 J/cm², and spot sizes of 3.1–3.9 cm². Some models (T14B, T16B, T19B) feature cooling panels around the light-emitting window; others (T15B, T17C, T18B, T21C, T21D, T25B, T25C) use sapphire-based cooling. All models include microprocessor control, skin contact sensors, and auto-recognition skin pigmentation sensors to detect appropriate skin tones and determine energy levels.

ISO 10993-5, 10993-10, 10993-23 (biocompatibility); IEC 60601-1, 60601-1-2, 60601-1-6, 60601-1-11, 60601-2-57, 60601-2-83 (electrical safety and EMC); IEC 62471 (photobiological safety).

The subject device has identical intended use, mode of action (IPL technology with Xenon flashlamp), and regulatory classification (Class II, OTC) as four predicate devices. Minor differences in wavelength range (510–1200 nm vs. 550–1200 nm), spot sizes, pulse duration, and maximum fluence fall within the ranges of existing predicates and comply with the same safety standards. The addition of skin pigmentation sensors is supported by predicates 2 and 3, which also feature this capability. All performance testing—biocompatibility, electrical safety, EMC, and photobiological safety—demonstrates equivalent safety and efficacy profiles to the predicates.