Erchonia DPN Laser (Model# EVRL)

The Erchonia® DPN Laser is a handheld, battery-operated low-level laser therapy device for prescription home use. It delivers non-thermal red (640 nm) and violet (405 nm) laser light to provide temporary relief of diabetic peripheral neuropathy foot pain as an adjunctive treatment.

The subject device uses two semiconductor laser diodes emitting red light at 7.5 mW and violet light at 7.5 mW, compared to the predicate's 5 mW violet output. Both devices share identical wavelengths, energy delivery method (handheld with line-pattern scanning), rechargeable lithium-ion batteries, and aluminum enclosures. The increased violet power (2.5 mW more) does not change the laser safety classification or risk profile, as demonstrated by clinical data.

The device complies with IEC 60601-1, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-1-2, and IEC 60825-1 standards. Safety and EMC testing was conducted per these voluntary consensus standards.

The Erchonia® DPN Laser is substantially equivalent to the predicate Erchonia® EVRL (K191257) because both devices share identical core technological characteristics including wavelength, energy source, delivery method, and intended non-thermal use in pain therapy. Clinical data from a prospective, placebo-controlled, double-blind study demonstrated that 72.73% of active-treatment subjects achieved ≥30% pain reduction versus 32.26% in placebo, establishing the predefined 35% success difference threshold. The minor increase in violet diode power is proportional and supported by clinical safety and effectiveness data showing no serious adverse events.