FEATHER 01 02 03 04 (Model:01)

The FEATHER 01 02 03 04 is an over-the-counter LED light device intended for treating wrinkles on the face. It emits three simultaneous wavelengths (630nm±10nm, 660nm±10nm, 850nm±10nm) and operates for 3 minutes per treatment session with adjustable intensity controlled by a single power button.

The device uses LEDs as the irradiance source with a maximum intensity of 70 mw/cm², powered by a 3.7V 500mAh lithium battery, and includes visual status indicators. It operates in the OTC environment on the face using red and near-infrared wavelengths within ranges demonstrated safe by predicate devices K221444 and K230042.

IEC 60601-1 (medical electrical equipment general safety), IEC 60601-1-2 (electromagnetic disturbances), IEC 60601-2-57 (non-laser light source equipment), IEC 60601-2-83 (home light therapy equipment), IEC 62133-2 (lithium battery safety), IEC 62471 (photobiological safety), IEC 62366-1 and IEC 60601-1-6 (usability).

The subject device is substantially equivalent because it uses identical treatment principles (LED-based wrinkle reduction), the same irradiance source type (LEDs), comparable intensity (70 mw/cm² vs. predicate 65-70 mw/cm²), and wavelengths fully covered by predicates that demonstrated safety. All devices underwent the same safety and performance standards testing, and no new safety or effectiveness questions arise from the minor differences in wavelength specification or power supply design.