Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)

The Facial & Body Beauty Device is a handheld, over-the-counter aesthetic device combining microcurrent stimulation and LED phototherapy. It features red light (630nm) for treating periorbital wrinkles and blue light (470nm) for mild to moderate inflammatory acne, with some models including only red light capability. The device is battery-powered, portable, and intended for home use on the face and body.

The device uses LEDs at 630nm (red) and 470nm (blue) wavelengths with intensities of 2.3 mW/cm² (red) and 4.48 mW/cm² (blue). It incorporates microcurrent stimulation mode, software-controlled operation, and an internal 3.7V 1100mAh lithium-ion battery. Key materials include PC, PC+ABS, and zinc alloy. Minor differences from predicates include larger dimensions (52×48×188mm), higher battery capacity, and different intensity levels, but these do not raise safety or efficacy concerns.

IEC 60601-1:2020 (electrical safety), IEC 60601-1-2:2020 (electromagnetic disturbances), IEC 60601-1-11:2020 (home healthcare environment), IEC 60601-2-83:2019 (home light therapy equipment), IEC 62471:2006 (photobiological safety), IEC 62133-2:2021 (lithium battery safety), ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (skin sensitization), and ISO 10993-23:2021 (skin irritation testing).

The subject device has the same intended use and technological principles as three predicate devices (K241718, K171821, K210545), utilizing LEDs for aesthetic purposes with comparable wavelengths and safety design. Non-clinical testing demonstrates equivalent electrical safety, biocompatibility, and software validation. Minor differences in dimensions, weight, and power specifications do not raise new safety or efficacy issues. The device is substantially equivalent to legally marketed predicates for over-the-counter wrinkle reduction and acne treatment.