The Lunula™ Laser targets onychomycosis through the use of two true laser beams (red 635nm and violet 405nm – monochromatic, collimated, and coherent).

The two wavelengths trigger a photochemical reaction, producing Reactive Oxygen Species which is converted to Hydrogen Peroxide – a natural antiseptic that kills onychomycosis.

In addition, the red 635nm wavelength induces the production of Adenosine Triphosphate (ATP) which is converted to Nitric Oxide – aiding the natural immune response in fighting the infection.

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: 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) Temporary Increase of Clear Nail in Patients With Onychomycosis (e.g., Dermatophytes Trichophyton Rubrum and T. mentagrophytes, and/or Yeasts Candida Albicans, etc.) (Lunula Laser ) — 2016 — Sponsor and monitor, IRB approved, blind, placebo controlled, clinical study.
FDA-clearance – K153164
To view NIH clinical trial records, click here.

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

3) 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.

4) 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

5) 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.

6) 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.

7) 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.

8) 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.

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

10) 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.

11) 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.

12) 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.

Nail fungus (onychomycosis) is one of the most common foot conditions worldwide. It affects an estimated 10% of the general population, with prevalence increasing to nearly 50% in people over the age of 70.

Because it is both unsightly and often difficult to treat with conventional options, demand for effective solutions is high. In fact, millions of people seek treatment each year — making nail fungus a significant and growing market opportunity for clinics.

With Lunula™ Laser, you can meet this demand by offering a safe, FDA-cleared, and effective solution that stands apart from creams, lacquers, and oral medications, which are often ineffective or come with unwanted side effects.

The efficacy of Lunula™ 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.

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

The Lunula™ treatments are just 12 minutes long and and fully automated, allowing you to save on staff costs and increase profits.

There are no code regulated contraindications, however, since there are no long-term evaluations on certain conditions, we do not recommend using Lunula™ 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.

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). The vast majority of HLLT devices have longer near-infrared wavelengths.
• 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 LLLT devices have shorter wavelengths.

There is a common misconception, often propagated by the manufacturers of Class 4 Lasers, 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. Laser light with wavelengths exceeding 950nm is highly absorbed by water, preventing much of its energy from penetrating the dermis. This strong absorption can also cause localised heating, leading to discomfort or pain, which may restrict its therapeutic application.
2. There is an optimal ‘dose’ of laser energy (typically 2-4 joules / cm²) required for therapeutic biostimulation. Deviating from this dose, either by providing significantly less or more energy, can be counterproductive. HLLT devices, with their substantial power outputs, risk surpassing this optimal range.
3. It is theorised that a minimum energy of 1.7eV per photon is required for therapeutic biostimulation via photochemical means – wavelengths exceeding 730nm cannot deliver this 1.7eV. As a result, HLLT devices, which often operate within these longer wavelengths, may not primarily function through inducing photochemical reactions. Instead, they might rely on alternative mechanisms, such as the therapeutic influence of localised heat generation. However, this approach may be less efficacious compared to biostimulation by photochemistry.

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.

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

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.

Erchonia® offers advanced laser lipo machines for non-invasive fat loss, clinically proven cold laser therapy devices for pain, and industry-leading nail fungus laser devices for treating onychomycosis.

Our FDA-cleared lasers deliver safe, effective solutions for 360° fat loss, body sculpting, cellulite reduction, pain management, pre- and post-surgical healing, rehabilitation, and the treatment of nail and skin pathologies — all without heat, downtime, or side effects.

Key products include XLR8®, EVRL®, GVL®, FX635®, FX405®, and Base Station for pain; Emerald™, Verjú®, and Zerona® for fat reduction; and the Lunula® Laser for fungal nail treatment — all backed by rigorous clinical research.

With over 25 years of experience, 18,000+ devices in the market, and 22 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 22 of the 25 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.