Contour Light (CL-100)

The Contour Light CL-100 is a non-invasive red light LED-based device used for aesthetic circumferential reduction of hips, waist, and thighs in adults over 30-minute treatment sessions. It also provides topical heating for temporary pain relief, muscle relaxation, and increased local blood circulation.

The device uses the same 635nm wavelength for fat reduction and 880nm wavelength for pain relief as the predicate, with identical 70 mW/cm² output intensity and 30-minute treatment time. Both are non-invasive LED systems with adjustable panels, software-controlled consoles, and medical-grade power adaptors.

Not stated in this summary.

The Contour Light CL-100 is substantially equivalent to predicate K202955 because it has identical intended use (same wavelengths, irradiance, treatment time, and body areas treated), identical technological characteristics, and a safe history of use. The primary difference is conversion from Rx to OTC use, supported by human factors and usability studies demonstrating 15 representative users could safely and effectively operate the device per labeling.