Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro)

This is an over-the-counter hair removal device using Intense Pulsed Light (IPL) technology for removal of unwanted body and facial hair. It comes in 10 models across two series (R3C16 and R3505), with differences primarily in enclosure color and cooling method (metal vs. sapphire treatment window). The device operates via external power adapter and includes a skin sensor to ensure proper contact before light emission.

The device uses a xenon arc flashlamp generating IPL in the 530–1200 nm wavelength range with energy density ranging from 1.39–7.5 J/cm² depending on model. Spot sizes range from 2.8–3.6 cm², pulse duration is 6–12 ms, and the device offers 9 output intensity levels controlled by finger switch. All models include cooling and microprocessor control; the main design difference is that 'Pro' models use sapphire versus metal treatment windows.

ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (skin sensitization), ISO 10993-23:2021 (irritation), IEC 60601-1:2020 and IEC 60601-1-2:2020 (electrical safety and EMC), IEC 60601-1-11:2020 (home healthcare use), IEC 60601-2-83:2022 (home light therapy equipment), IEC 62471:2006 (photobiological safety), and IEC 60601-1-6:2020 (usability).

The subject device shares the same intended use (OTC hair removal), identical mode of action (IPL-based), and substantially similar technological characteristics as the predicate devices in wavelength range, energy density, spot size, pulse duration, and control methods. While minor differences exist in dimensions and cooling window materials, these do not raise safety or efficacy concerns. Non-clinical testing demonstrates the device meets applicable biocompatibility and electrical safety standards equivalent to the predicates, supporting the conclusion that it is as safe and effective.