All studies carried out to obtain FDA-clearance are double blind, randomised, placebo-controlled, and multi-site – the most credible research in the market.

The following list shows the clinical trials and an outline of their progress. As a company, to protect our intellectual assets, not all clinical trials we are involved with are made public so as to maintain our competitive advantage. As such, not all clinical trials are listed below.

Please note: EVRL® is new in series – several clinical studies were performed on its predecessors (with the same mechanisms of action).

Please also note: There are hundreds of clinical studies confirming the effectiveness of Low-Level Laser Therapy (LLLT), and every year there are many new publications. Below is a list of Erchonia-specific studies for FDA-clearance.

1) Market Clearance for Relief of Chronic Musculoskeletal Pain (FX 635) — 2019 — A collection of placebo-controlled, randomized, double-blind, parallel-group, multi-center clinical studies.
FDA-clearance – K190572

2) Market Clearance to Treat Chronic Low Back Pain (FX 635) — 2018 — Placebo-controlled, randomized, double-blind, parallel-group, multi-center clinical study.
FDA-clearance – K180197
To view NIH clinical trial records, click here.

3) Erchonia EVRL (EVRL) – 2016
a. while using the red diode, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
b. and while using the violet diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.
FDA-clearance – K152196

4) Adjunct to Chronic Heel Pain Arising from Plantar Fasciitis Using the Erchonia FX635 Laser — 2012 — Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
FDA-clearance – K132940
Study results published in the American Orthopaedic Foot & Ankle Society April 2014
To view NIH clinical trial records, click here.

5) Equine Wound Healing – 2011 — Sponsor, placebo controlled, clinical study.
Study completed from Feb. 2011-April 2011.
Monitored by Hank Jann, DVM, MS, DAVCS from Oklahoma State University.

6) Equine Wound Healing – 2011 — Sponsor, Case Study.
Study completed from Nov. 2010-March 2011.
Monitored by Hank Jann, DVM, MS, DACVS from Oklahoma State University.

7) Pain Associated With Breast Augmentation Surgery / Low-Level Laser — 2007 — Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
Results used to obtain FDA-clearance – K072206
To view NIH clinical trial records, click here.

8) Acne Vulgaris — Dermatological Conditions / Low-Level Laser — 2005 — Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
FDA-clearance – K050672

9) Low-Level Laser Light Therapy as an Aid to Liposuction and Reduction of Pain Associated With Surgery — 2004 — Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
Study results used to obtain FDA-clearance – K041139
To view NIH clinical trial records, click here.

10) Chronic Neck and Shoulder Pain / Low-Level Laser — 2001 — Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
Study results used to obtain FDA-clearance – K012580
To view NIH clinical trial records, click here.

11) Chronic Neck and Shoulder Pain / Low-Level Laser — 2000 — Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
First study done in support of 510(k) submission, second study requested by FDA.

Put simply, EVRL® delivers parcels of light energy into the cell which the cell can use, and the parcels are delivered in the most effective and efficient way. This added energy fuels key processes, stimulating healing, relieving pain, reducing inflammation, and restoring function.

The EVRL® emits two true laser beams – a red laser promotes healing through its 635nm beam (7.5mW output), and a violet laser provides an antimicrobial effect through its 405nm beam (5mW output). Please watch this video for more information:

While the benefits of Low-Level Laser Therapy (LLLT) have been observed in hundreds of medical studies, the exact mechanisms that lead to these results are still being explored. Although we still have a lot to learn about the effects of light energy on different types of cells, the leading theory is that LLLT generates therapeutic effects through stimulating and enhancing specific biochemical processes within cells.

More specifically, utilising the first law in photochemistry (Grotthuss-Draper law), laser energy is transferred to cytochrome c oxidase (CcO) – a respiratory energy-transducing enzyme which is involved in the electron transport chain in mitochondria. This energy transfer causes photodissociation of inhibitory nitric oxide from CcO, leading to an enhancement of enzyme activity, electron transport, mitochondrial respiration, and adenosine triphosphate (ATP) production. Consequently, by altering the cellular redox state, LLLT induces the activation of numerous intracellular signalling pathways, and alters the affinity of transcription factors concerned with cell proliferation, survival, repair, and regeneration.

EVRL® utilises true laser technology, optimising photonic energy delivery through the use of monochromatic, collimated, and coherent beams of light. That is, the light emitted by a true laser is composed from photons that have the same wavelength (monochromatic), travel in the same direction / do not disperse (collimated), and are in phase in space and time (coherent). These three properties of true lasers make them the most effective and efficient devices within the Laser Therapy sector.

EVRL® was specifically designed to deliver the optimal amount of energy required to stimulate and enhance cell function while not damaging cells or producing painful heat sensations. The device emits two true laser beams – a red laser promotes healing through its 635nm beam (7.5mW output), and a violet laser provides an antimicrobial effect through its 405nm beam (5mW output). EVRL® is classified as a ‘Class II Laser’ by the FDA in virtue of it’s low output and very low risk of hazard (Download Datasheet).

Clinical studies and trials of Laser Therapy technologies indicate the following beneficial effects of Low-Level Laser Therapy (LLLT).

1. Anti-Inflammation. LLLT creates an anti-edema effect by dilating blood vessels and activating the lymphatic drainage system (which drains swollen areas). This reduces swelling caused by trauma or inflammation.
   
2. Anti-Pain (Analgesic). LLLT exerts a very beneficial effect on pain in multiple ways: It partially blocks neural transmission of pain signals to the brain; It decreases nerve sensitivity; It lessens pain by reducing edema; It helps to increase the production of high levels of painkilling chemicals such as endorphins, enkephalins, and opioids from the brain and adrenal gland.
3. Accelerated Tissue Repair and Cell Growth. Photons of light from lasers penetrate deeply into tissues and accelerate cellular reproduction and growth. The laser light also increases the energy available to the cell by increasing ATP production so that the cell can take on nutrients faster and get rid of waste products. As a result of exposure to laser light, all cells, including the cells of tendons, ligaments, and muscles, are repaired faster.
4. Improved Vascular Activity. LLLT significantly increases the formation of new capillaries in damaged tissue, which speeds up the healing process, closes wounds more quickly, and reduces scarring. LLLT also causes vasodilation – an increase in the diameter of blood vessels – which improves the delivery of blood and healing elements to damaged tissues.
5. Increased Metabolic Activity. LLLT stimulates higher outputs of specific pro-healing enzymes in blood cells, along with improved oxygen and nutrient delivery.
6. Trigger Points and Acupuncture Points. LLLT stimulates muscle trigger points and acupuncture points on a non-invasive basis, providing musculoskeletal pain relief.
7. Reduced Fibrous Tissue Formation. LLLT reduces the formation of scar tissue following damage from cuts, scratches, burns, or surgery.
8. Improved Nerve Function. Slow recovery of nerves in damaged tissue results in impaired sensory and motor function. LLLT speeds up the process of axonal regeneration and nerve cell reconnection, and increases the amplitude of action potentials to optimize muscle action.
9. Immunoregulation. LLLT directly affects immunity status by stimulating the production of immunoglobulins and lymphocytes, and by improving the ease of penetration of white blood cells into damaged tissue.
10. Faster Wound Healing. LLLT stimulates fibroblast development in damaged tissue. Fibroblasts are the building blocks of collagen, which is the essential protein required to replace old tissue or repair tissue injuries. As a result, LLLT is effective on open wounds and burns.

EVRL® can help a wide variety of patients, including: Orthopaedic pain – sprains, whiplash, muscular pain, cervical or lumbar radiculopathy, tendinitis, and carpal tunnel syndrome. The device has also shown positive effects on individuals with chronic conditions like arthritis and osteoarthritis, and in treating post-surgical pain; Neuropathic pain, including various types of neuralgia and diabetic neuropathy; Pain management for athletes recovering from training or injuries; Bacterial, fungal, or viral infections.

The efficacy of EVRL® has been scientifically proven with double blind, randomised, placebo-controlled, and multi-site studies. Many competing companies advertise their products as ‘clinically proven’, guaranteeing ‘instant results’. However, these claims are often not backed by comprehensive clinical evidence.

Several companies have FDA-clearance within the Laser Therapy sector, however, in most cases the intended use / indications of their products are quite limiting or not relevant to the marketed applications. Furthermore, these FDA-clearances are often obtained without any scientific research.

We always recommend that you ask for details of the FDA-clearances and make an informed decision. Pay particular attention to the scope of the clearance, whether it involved clinical studies, how many patients participated, were the studies placebo controlled, double blind, and randomised, how many peer reviewed published articles they have, and what the adverse reactions / side effects were – we would be happy to provide this information for you.

To understand the difference between the various types of Laser Therapy devices, it is first important to distinguish between High-Level Laser Therapy (HLLT) and Low-Level Laser Therapy (LLLT):

• HLLT devices are classified as ‘Class IV Lasers’ by the FDA in virtue of having a power output that’s greater than 500mW (i.e. high risk of hazard).
• LLLT devices are classified as either ‘Class IIIB Lasers’, ‘Class IIIR Lasers’, or ‘Class II Lasers’ in virtue of having a power output of 5-500mW, 1-5mW, or <1mW respectively (i.e. lower risk of hazard).

The vast majority of HLLT devices have longer near-infrared (NIR) wavelengths – there is a common misconception, often propagated by the manufacturers of such devices, that high power with longer wavelengths results in:

1. Deeper penetration, allowing for the treatment of a wider range of conditions.
2. More efficacious results (due to the delivery of more energy into the cells).

This however, is not correct for the following well-documented reasons:

1. Due to the high absorption rate of laser light by water at wavelengths greater than 950nm, most of the energy produced at this wavelength (or above) is absorbed before penetrating the dermis.
2. The key principle behind Laser Therapy is to generate therapeutic effects by stimulating and enhancing specific biochemical processes within cells (c.f. ‘What is the Technical Explanation for How EVRL® Works?’ FAQ). However, there is an optimal ‘dose’ of laser energy (typically 2-4 joules / cm²) required for stimulating and enhancing the desired biochemical processes – HLLT devices exceed this optimal level.

Put simply, HLLT devices deliver too much energy at inefficient wavelengths, resulting in a lack of efficacy and increased costs.

To add to this, the high outputs used by such devices produce painful heat sensations, further limiting their scope of treatment.

In essence, HLLT devices should only be used for laser surgery and tissue ablation – the high outputs are effective for cell destruction, but are not suited for therapeutic purposes, contrary to the claims of Class IV manufacturers.

LLLT devices, on the other hand, aim to deliver energy via low output, short wavelength beams of light. The general theory is that this approach transfers the optimal amount of energy for stimulating and enhancing cell function, while not damaging cells or producing painful heat sensations.

Within the LLLT sector however, some of the higher output devices still generate heat / pain. Furthermore, many devices are advertised as ‘lasers’, when in fact they are Light Emitting Diodes (LEDs) or Superluminescent Diodes (SLDs). In contrast to LEDs or SLDs, ‘true’ lasers generate monochromatic, collimated, and coherent beams of light. These three properties of true lasers make them the most effective and efficient LLLT devices (c.f. ‘What is the Technical Explanation for How EVRL® Works?’ FAQ).

To separate EVRL® from such technologies, and from HLLT more generally, we say that the EVRL® is a ‘non-thermal, true laser’. That is, the EVRL® does not produce any heat or painful sensations, and is monochromatic, collimated, and coherent.

There are no code regulated contraindications, however, since there are no long-term evaluations on certain conditions, we do not recommend using EVRL® on pregnant women, clients with a pacemaker, or clients with photosensitive epilepsy. We also do not recommend using the device over an area of known cancer.

EVRL® is a true Non-Thermal Low-Level Laser and causes no pain or health risks.

The EVRL® treatments are just 10-30 minutes long and are relaxing to administer, allowing you to take the pressure off your hands and body.

Erchonia® lasers are used in many areas, such as 360-degree fat loss, body sculpting, cellulite reduction, pain management, pre / postsurgical healing, pre / rehabilitation, and nail and skin pathologies (e.g. onychomycosis (nail fungus), acne, and more).

Not only do our lasers treat specifics, but they also empower the body to function efficiently due to the beneficial effects they have on our cells.

With over 25 years of experience, 16,000+ devices in the market, and 21 FDA-clearances, Erchonia® Corporation are world leaders in medical-grade Laser Therapy technology for physicians, chiropractors, physical therapists, podiatrists, osteopaths, aesthetics clinics, veterinarians, and many other types of medical / health professionals.

Erchonia® own 21 of the 24 FDA-clearances given to Low-Level Lasers, and the efficacy of our devices has been proven by multiple (level 1) double blind, randomised, placebo-controlled, and multi-site clinical studies – the most credible research in the market today.

All Erchonia® laser systems are cut from raw materials, and all of our products go through a rigorous quality control process before delivery to our customers around the world. As a company, we are 85% self-reliant in all facets of our organisation, and all of our products are FDA, ISO, OSHA, and MDSAP compliant.

The Erchonia® mission statement is simply “Quality Not Compromise”, and this is ingrained in every aspect of our business – from an unwavering belief in the limitless potential applications of Low-Level Lasers, down to the care and quality of the smallest component of our devices. Just pick up any Erchonia® product, feel the quality of workmanship, and see the attention to detail that can only come from Erchonia’s near-complete control of the manufacturing and assembly processes that go into each product bearing the Erchonia® name.