LMNT O2

The LMNT O2 is a handheld, over-the-counter LED-based device for home use that emits red and infrared light (633nm and 830nm wavelengths) to treat periorbital wrinkles, and blue light (415nm) to treat mild to moderate acne on the face. It uses 36 LEDs distributed over 10 cm² with uniform power density and no hot spots.

The device employs 36 LEDs (12 at each of 633nm, 830nm, and 415nm) over 10 cm² with energy densities of 69 mW/cm² (633nm), 53 mW/cm² (830nm), and 49 mW/cm² (415nm). It uses a lithium battery, rigid ABS and stainless steel construction, and delivers constant waveform output. Treatment protocols specify 3 times weekly for 15-20 minutes (red mode) or twice weekly for 4 minutes (blue mode) over 4 weeks.

Electrical safety (ANSI AAMI ES60601-1:2005 and amendments), electromagnetic compatibility (IEC 60601-1-2 Edition 4.1), home healthcare use (IEC 60601-1-11 Edition 2.1), photobiological safety (IEC 62471), biocompatibility (ISO 10993-5, 10993-10, 10993-11, 10993-23), plus skin temperature, LED wavelength/power density, and no hot spots performance testing.

The device is substantially equivalent because it shares the same intended use (dermatological treatment of wrinkles and acne via LED light), same device type (handheld OTC), same materials (ABS and stainless steel), same light source technology (LEDs at comparable wavelengths), similar energy densities and treatment protocols, and same anatomical sites as predicate devices K232656 and K181659. Non-clinical testing demonstrates equivalent safety and performance across electrical, EMC, biocompatibility, and optical performance metrics.