Clinical Evidence
The Erchonia-DPN Laser's FDA clearance (K251903) is supported by clinical evidence demonstrating safety and effectiveness in treating symptoms of diabetic peripheral neuropathy.
Pain Reduction Over Time
Clinical study participants experienced progressive reduction in pain scores throughout the treatment period, with results maintained at 4 weeks post-treatment, demonstrating the durability of pain reduction after treatment ended.
Average pain reduction from baseline
Pain Score (0-100 Scale)
Post-treatment measurement was taken 4 weeks after the final treatment, demonstrating durability of pain reduction.
Symptom Improvement Outcomes
Across multiple symptom categories, patients experienced meaningful improvement.
Why Medical Laser Technology Matters
Not all light therapy is created equal.
Many products marketed today as "red light therapy" use inexpensive LED technology and are sold as general wellness products. While they may appear similar, they are fundamentally different from the precision medical laser technology used in the Erchonia-DPN System.
The Erchonia-DPN System utilizes true medical-grade laser technology specifically engineered for therapeutic applications and evaluated in a randomized, placebo-controlled clinical study supporting FDA clearance.
For the placebo group in our clinical study, patients were treated using an LED placebo device designed to simulate treatment without delivering the therapeutic laser treatment being evaluated.
The results clearly demonstrated the difference.
72.7% of patients treated with the Erchonia medical laser achieved at least a 30% reduction in diabetic peripheral neuropathy pain.
Patients treated with the Erchonia medical laser achieved a 40.5 percentage-point greater clinical success rate than patients treated with the LED placebo device.
The Erchonia medical laser demonstrated a 125% higher clinical success rate than the LED placebo device in the randomized clinical trial.
Erchonia Medical Laser
- True medical-grade laser technology
- Precision-engineered therapeutic laser
- Coherent, collimated laser light
- FDA-cleared prescription medical device
- Evaluated in a randomized controlled clinical study
- Clinically demonstrated significant reduction in diabetic peripheral neuropathy pain
- Specifically developed for prescription home treatment
- Physician prescribed and monitored
Typical Consumer LED Devices
- Non-focused, non-coherent, non-collimated light source
- General wellness products
- Not FDA cleared for the treatment of diabetic peripheral neuropathy
- Lack published randomized clinical evidence demonstrating effectiveness for diabetic peripheral neuropathy
- Product quality, output, and performance vary widely
- Not prescription medical devices
Clinically Proven. FDA Cleared.
Unlike many over-the-counter light therapy products, the Erchonia-DPN System was evaluated in a randomized, placebo-controlled clinical trial using an LED placebo device. Patients treated with the Erchonia medical laser demonstrated a 40.5 percentage-point greater clinical success rate, supporting FDA clearance for prescription home treatment of diabetic peripheral neuropathy.
Safety Profile
No adverse events reported
The remaining 4% were mild and transient, requiring no medical intervention.
Key Findings
Statistically significant reduction in pain scores compared to baseline
Improvement in sensory function as measured by standardized assessments
No serious adverse events reported during the clinical study
Sustained symptom improvement through follow-up period
High patient compliance with at-home treatment protocol
Treatment well-tolerated across all study participants