IPL Hair Removal Device (BE965A, BE965B, BE965C)

The IPL Hair Removal Device (BE965A, BE965B, BE965C) is an over-the-counter, light-based device that uses Intense Pulsed Light (IPL) technology to remove unwanted body and facial hair. The device operates below the skin's surface without cutting or pulling, includes a skin sensor to detect proper contact, and features sapphire cooling for user comfort.

The device uses the same light source (Intense Pulsed Light), energy medium (Xenon Arc Flash lamp), wavelength (600-1200 nm), and power supply (100-240V external adapter) as predicate devices. Energy density ranges from 2.75-6.56 J/cm² (within the predicate range of 1.67-6.67 J/cm²), and the device employs double-pulse output with duration 0.82-5.32 ms, which falls within the reference device range of 0.88-6.6 ms.

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83, IEC 62471, IEC 60601-1-6, IEC TS 60601-4-2, ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-23. Device software was evaluated per FDA guidance on premarket submissions for device software functions.

The subject device operates on identical principles and uses the same technological platform (IPL with Xenon Arc lamps at 600-1200 nm wavelength) as multiple legally marketed predicates. Although dimensional and operational parameters differ slightly, the energy density and pulse characteristics remain within the established ranges of predicate devices, with no safety or effectiveness concerns raised. The device meets all applicable international standards for medical electrical equipment and photobiological safety, supporting functional and performance equivalence to predicate devices for the same intended use of hair removal.