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FDA Clearances
Erchonia establishes new indications through double-blind, randomized, multi-site, placebo-controlled clinical trials — the highest standard in clinical testing. Most cleared devices never run one.
Each pain indication below was a first of its kind for laser therapy — part of Erchonia’s 25 FDA clearances.
Our Journey Through Time
2002
Chronic Neck & Shoulder Pain
2004
Post-Surgical Pain after Liposuction
2008
Post-Surgical Pain after Breast Augmentation
2014
Chronic Plantar Fasciitis Pain
2018
Chronic Low Back Pain
Neck & Shoulder Pain
Red + Violet
Red + Violet
2019
Overall Nonspecific Musculoskeletal Pain
2021
Overall Post-Operative Pain
2022
Neck & Shoulder Pain — Green + Violet
2025
Body Circumference Reduction — Zerona VZ8
2026
Diabetic Peripheral Neuropathy Foot Pain
“…set the precedent on how aesthetic devices should be evaluated.”
On Erchonia’s Zenora research
Three Harvard scientists · Lasers in Surgery & Medicine
HOW RARE THIS STANDARD IS
Over 90%
of 510(k) devices clear with no new clinical trial data — on equivalence to an earlier device plus bench testing.
OUR CONTROL ARM IS AN LED
In these trials the placebo device is an LED — the same light sold elsewhere as therapy. The laser beat it every time. Figures show laser / LED sham.
65.1% | 11.6%
NECK & SHOULDER
74% | 37%
POST-OP PAIN
66.5% | 17.2%
MUSCULOSKELETAL
Download the Complete FDA Clearances Guide
