Feather/numiere 05 06 07 (05)

The Feather/numiere 05 06 07 (Model 05) is an over-the-counter LED device that emits red light at 630nm±10nm and near-infrared light at 830nm±10nm wavelengths to treat wrinkles on the neck and decolletage (upper chest). The flexible silicone panel contains LEDs controlled by buttons that regulate intensity and treatment duration, with treatments lasting 10 minutes, 5 times weekly for 6 weeks.

The device emits simultaneous dual wavelengths (630nm and 830nm) with a maximum irradiance of 30mW/cm² at three adjustable intensity levels. It is powered by a 5V lithium battery (3.7Vdc, 1200mAh) via an AC adapter and includes a controller displaying intensity and treatment time. Key standards compliance includes IEC 60601 series for safety and electromagnetic compatibility, IEC 62133-2 for lithium batteries, IEC 62471 for photobiological safety, and IEC 62366-1 for usability.

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, IEC 60601-2-83, IEC 62471, IEC 62133-2, IEC 62366-1, and IEC 60601-1-6. Non-clinical testing included electrical safety, electromagnetic compatibility, software verification and validation at moderate concern level, and usability validation.

The subject device is substantially equivalent to predicate devices K223147 (myLEDmask) and K242382 (décoLITE) because all three are Class II OTC LED devices using identical or nearly identical wavelengths (630nm and 830nm), the same irradiance source (LEDs), comparable maximum intensities (30mW/cm²), and equivalent treatment protocols for wrinkle reduction. Differences in specific location of use (decolletage versus full-face) and power supply design do not raise new safety or effectiveness questions given compliance with the same applicable standards.