Erchonia EVRL

The Erchonia EVRL is a handheld, over-the-counter device that emits blue light (405 nm) and red light (640 nm) to treat mild to moderate acne. It operates as a non-thermal, non-contact treatment designed for use 1–3 inches from the skin, with a preset treatment protocol, touchscreen interface, and automatic shutoff after the treatment cycle completes.

The EVRL is handheld with dual wavelengths (405 nm blue and 640 nm red, each ±10 nm), delivers 9 joules total dose (4.5 joules per wavelength), emits light in combination mode rather than sequential, uses a lithium-ion battery power source, features a 0.5–3.048 cm² line-pattern aperture, and operates at 15 mW/cm² power density for each wavelength.

IEC 60601-1:2005+AMD1:2012+AMD2:2020 (general medical device safety), IEC 60601-1-2:2014+AMD1:2020 (EMC), IEC 60601-1-11:2015+AMD1:2020 (home healthcare), IEC 60825-1:2014 (laser safety), and FDA's 21 CFR 1040.10 and 1040.11 for light-emitting products. Usability testing complied with IEC 62366-1 and IEC 60601-1-6; risk management followed ISO 14971.

The EVRL shares the same intended use (mild to moderate acne treatment) and key technological features as the primary predicate (The Luminance RED Acne Device): identical handheld form, similar dual-wavelength design with overlapping spectral ranges, equivalent total dose of 9 joules, matching treatment regimen (2× daily), same lithium-ion power source, and comparable aperture size. Minor differences—such as 15 mW/cm² vs. 50 mW/cm² power density, line vs. circular aperture pattern, and simultaneous vs. sequential light emission—do not raise new safety or effectiveness questions because they remain within the established therapeutic envelope demonstrated by the predicate devices.