An Introduction to Photobiomodulation & Low-Level Laser Therapy (LLLT)
The human body uses light-induced photochemical reactions on a daily basis. From the photosensitive cells in our eyes to the light-reliant vitamin D synthesis process in our skin, our bodies rely on and can use light in numerous ways. It stands to reason then, that many cells in the human body may react to light. So how does light affect cells in the body, and how can it be used for the benefit of human health? That is the question behind the treatment method called Photobiomodulation (PBM) Therapy, commonly known as Low-Level Laser Therapy (LLLT) or Cold Laser Therapy (though within the PBM Therapy sector it is important to distinguish between Low-Level Laser Therapy and High-Level Laser Therapy for the reasons explained below).
What Is Photobiomodulation (PBM) Therapy?
Photobiomodulation Therapy is a term that describes the therapeutic application of light to the body. First developed in 1967 by Endre Mester in Hungary, PBM Therapy involves placing a light source near to or on the skin, allowing the photons to move through the tissue and interact with cells in the body. Mester first developed this method after discovering that it improved hair growth and stimulated wound healing in mice. Shortly after his initial development of the treatment method, Mester explored the therapy’s ability to aid in the healing of skin ulcers in 1972.
Since the development of the procedure, the benefits of PBM Therapy have been studied at length – the photochemical changes that occur in cells as a reaction to the application of light can help to manage pain, accelerate wound healing, enhance tissue regeneration, increase circulation, reduce inflammation, remove fat and cellulite, treat fungal nail infections, clear acne, and more.
How Does Photobiomodulation (PBM) Therapy Work?
While the benefits of Photobiomodulation Therapy 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 general consensus is that PBM Therapy works primarily by affecting the mitochondria inside human cells.
The primary principle behind photobiology is that when light hits certain molecules, called chromophores, the energy of the photon causes electrons in those molecules to be excited and jump into higher-energy orbits, effectively storing energy within the molecule. The mitochondria of the cell are thought to contain such chromophores, allowing them to store more energy to be used in the biochemical processes that mitochondria complete. Mitochondria then use this energy to increase the production of essential substances in the body. The most important of these are the following:
Adenosine Triphosphate (ATP): ATP is the energy storage molecule for the human body, used in virtually all of the biochemical processes that allow us to function. This includes processes that help our bodies to grow and heal.
Reactive Oxygen Series (ROS): ROS is a mild oxidant that is essential in the gene transcription process, which is a critical part of cellular repair and healing.
Nitric Oxide (NO): NO is an essential molecule in the body’s cellular communication system, helping transmit signals throughout the body, which can help improve overall body healing. NO is also helpful in dilating blood vessels to improve circulation.
Several other mechanisms are likely improved through the use of PBM Therapy. For example, NO improves the production of cyclic guanine monophosphate, which is involved in other signalling pathways in the body. PBM Therapy also improves the synthesis of DNA and RNA, which in turn promotes the production of proteins and growth factors.
What Are the Benefits of Photobiomodulation (PBM) Therapy?
The benefits of Photobiomodulation Therapy have been explored in hundreds of clinical studies – below is a short summary of some key findings and the leading theories about mechanism of action:
- Anti-Inflammation. PBM Therapy 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.
- Anti-Pain (Analgesic). PBM Therapy 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.
- 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.
- Improved Vascular Activity. PBM Therapy significantly increases the formation of new capillaries in damaged tissue, which speeds up the healing process, closes wounds more quickly, and reduces scarring. PBM Therapy also causes vasodilation – an increase in the diameter of blood vessels – which improves the delivery of blood and healing elements to damaged tissues.
- Increased Metabolic Activity. PBM Therapy stimulates higher outputs of specific pro-healing enzymes in blood cells, along with improved oxygen and nutrient delivery.
- Trigger Points and Acupuncture Points. PBM Therapy stimulates muscle trigger points and acupuncture points on a non-invasive basis, providing musculoskeletal pain relief.
- Reduced Fibrous Tissue Formation. PBM Therapy reduces the formation of scar tissue following damage from cuts, scratches, burns, or surgery.
- Improved Nerve Function. Slow recovery of nerves in damaged tissue results in impaired sensory and motor function. PBM Therapy speeds up the process of axonal regeneration and nerve cell reconnection, and increases the amplitude of action potentials to optimize muscle action.
- Immunoregulation. PBM Therapy 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.
- Faster Wound Healing. PBM Therapy 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, PBM Therapy is effective on open wounds and burns.
- Fat Removal. PBM Therapy helps induce adipocyte apoptosis, releasing stored fat from the body.
- Fungal Nail Treatment. PBM Therapy triggers a photochemical reaction, producing Reactive Oxygen Species which is converted to Hydrogen Peroxide – a natural antiseptic that kills onychomycosis.
What Are the Applications of Photobiomodulation (PBM) Therapy?
While Photobiomodulation Therapy has numerous potential benefits that are still being researched, several practical applications are already on the market. Below are a few of the more common areas in which Erchonia Corporation specialises:
- Pain Management
Pain is the most common reason that people see doctors in the UK and Europe, with more than one in three people affected by chronic pain each year. Photobiomodulation treatment has been explored in clinical studies as a way of decreasing several types of pain, including:
Orthopaedic pain: PBM Therapy has had pain-reducing effects on patients recovering from sprains, whiplash, muscular pain, cervical or lumbar radiculopathy, tendinitis, and carpal tunnel syndrome. It has also shown positive effects on individuals with chronic conditions like arthritis and osteoarthritis, and in treating post-surgical pain.
Neuropathic pain: Neuropathic pain conditions can be treated effectively with PBM Therapy, including various types of neuralgia and diabetic neuropathy.
PBM Therapy has also been effective in managing pain for athletes recovering from training or injuries – it is thought that PBM Therapy helps by stimulating the nerve endings of nociceptors, or pain receptors, that lie close to the skin.
- Fat Removal
Multiple studies have been conducted to determine whether Photobiomodulation Therapy can be used for fat reduction, with very positive results. One review found that PBM Therapy is effective at reducing fat and cellulite and improving blood lipid profiles with little to no side effects. The current theory as to why PBM Therapy is so effective in this area is that it helps induce adipocyte apoptosis, releasing stored fat from the body.
- Fungal Nail Treatment
PBM Therapy has been shown to effectively treat nail fungus (onychomycosis). The treatment triggers a photochemical reaction, producing Reactive Oxygen Species which is converted to Hydrogen Peroxide – a natural antiseptic that kills onychomycosis.
What Is the Technical Difference Between Types of Photobiomodulation (PBM) Therapy Devices?
To understand the difference between the various types of Photobiomodulation 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:
- Deeper penetration, allowing for the treatment of a wider range of conditions.
- More efficacious results (due to the delivery of more energy into the cells).
This however, is not correct for the following well-documented reasons:
- 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.
- The key principle behind PBM Therapy is to generate therapeutic effects by stimulating and enhancing specific biochemical processes within cells (c.f. ‘How Do Erchonia® Lasers for Pain Relief Work?’ 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. ‘How Do Erchonia® Lasers for Pain Relief Work?’ FAQ).
To separate Erchonia® from such technologies, and from HLLT more generally, we say that Erchonia® lasers are ‘non-thermal, true lasers’. That is, our lasers do not produce any heat or painful sensations, and are monochromatic, collimated, and coherent (to learn more, please read Class 4 Lasers, Class 3 Lasers, and Class 2 Lasers).
Common FAQs About Erchonia®
What Is the Scientific Evidence Behind Erchonia® Lasers?
All studies carried out to obtain FDA-clearance are double blind, randomised, placebo-controlled, and multi-site – the most credible research of all Photobiomodulation Therapy devices on the market today.
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 PBM Therapy, and every year there are many new publications. Below is a list of Erchonia-specific studies for FDA-clearance.
1) 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.
2) Chronic Neck and Shoulder Pain / Low Level Laser — 2001 — Sponsor and monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
3) 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.
4) Acne Vulgaris — Dermatological Conditions / Low Level Laser — 2005 — Sponsor and monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
- FDA clearance – K050672
5) Pain Associated With Breast Augmentation Surgery / Low Level Laser — 2007 — Sponsor and monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
6) Non-Invasive Fat Reduction and Body Contouring – Laser Scanner Waist, Hips, and Thighs — 2009 — Sponsor and monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
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) 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.
9) Arm Circumference Reduction of the Upper Arms — 2011 — Sponsor and monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
- Study results used to obtain FDA clearance – K120257
- Study submitted to be published 2012.
- To view NIH clinical trial records, click here.
10) Appearance of Cellulite (Verju Laser System) — 2012 — Sponsor and monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
- FDA clearance – K130922
- Study submitted to be published 2013.
- To view NIH clinical trial records, click here.
11) Non-Invasive Body Contouring Using GLS Laser – 532 nm (Green) Trade Name Verju — 2012 — Sponsor and monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
- FDA clearance – K123237
- Study submitted to be published 2013.
- To view NIH clinical trial records, click here.
12) 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.
13) Non-Invasive Dermatological Aesthetic Treatment for Reduction of Circumference of Hips, Waist and Upper Abdomen When Applied to Individuals with a Body Mass Index (BMI) Between 30 kg/m2 and 40 kg/m2 — 2013 – Sponsor and monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
14) Non-Invasive Dermatological Aesthetic Treatment for the Reduction of Circumference of Hips, Waist and Thighs (Zerona-Z6 OTC) — 2012 — Sponsor and monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
15) Non-Invasive Dermatological Aesthetic Treatment for the Reduction of Circumference of Hips, Waist, Thighs and Upper Abdomen — 6 Week Treatment Protocol (Zerona-Z6) — 2014 — Sponsor and monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
16) 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
17) 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.
18) Non-Invasive Dermatological Aesthetic Treatment for the Reduction of Body Circumference (Zerona-Z6) — 2016.
- FDA clearance – K162578
19) Market Clearance to Treat Chronic Low Back Pain (FX 635) — 2018 — Placebo-controlled, randomized, double-blind, parallel-group, multi-center clinical study.
20) 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
21) Non-Invasive Dermatological Aesthetic Treatment for the Reduction of Body Circumference in Individuals With a Body Mass Index (BMI) of up to 40 kg / m² — 2019 — The data used to get this approval combined all previous data Erchonia® had on 20-40 BMI patients in the green laser studies above.
What Is the Difference Between Erchonia® and Other Technologies in This Market?
The efficacy of Erchonia® lasers 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 Photobiomodulation 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.
How Do Erchonia® Lasers for Pain Relief Work?
While the benefits of Photobiomodulation Therapy 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 PBM Therapy 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, PBM Therapy induces the activation of numerous intracellular signalling pathways, and alters the affinity of transcription factors concerned with cell proliferation, survival, repair, and regeneration.
Erchonia® pain relief lasers utilise 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 PBM Therapy sector.
Erchonia® lasers were 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 – all of our non-thermal PBM Therapy devices are classified as ‘Class II Lasers’ by the FDA in virtue of their low output and very low risk of hazard.
How Do Erchonia® Lasers for Fat Removal Work?
Erchonia® fat removal lasers create a small transitory pore for the fatty liquids in fat cells to seep out. The fatty liquids are then naturally flushed out through the lymphatic system.
The result is that the fat cells shrink instead of being killed. When this happens, the shrunken fat cells begin to act and function like healthy lean cells, releasing the correct messages to the brain and creating a communication effect throughout the fat organ, causing other fat cells to release their content and return their hormone responses to the positive.
Procedures that have been popular in the past (such as fat freezing) focus on the elimination of fat cells, but recent research has shown this approach to be ineffective, and in the worst-case scenario, providing counterproductive results as the fat may regenerate in other parts of the body, or worse, around the organs.
Erchonia® lasers effectively train fat cells to behave and react differently, and all without excessive heat or cooling.
How Do Erchonia® Lasers for Fungal Nail Treatment Work?
Erchonia® lasers for fungal nail treatment target 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.
What Conditions Can Erchonia® Pain Relief Lasers Help With?
Erchonia® pain relief lasers can help a wide variety of patients, including: Orthopaedic pain – sprains, whiplash, muscular pain, cervical or lumbar radiculopathy, tendinitis, and carpal tunnel syndrome. Our devices have 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.
What Areas Do Erchonia® Fat Removal Lasers Treat?
Erchonia® lasers for fat removal treat overall body circumference while also allowing your clients to target stubborn areas of fat and cellulite.
Most people who undergo the treatments focus on their midriff and thighs, but the device can also target any area of subcutaneous fat, including bra strap, upper arms, jowls, knees, and more.
Are There Any Conditions Which Would Prevent Patients From Receiving the Treatments?
There are no code regulated contraindications, however, since there are no long-term evaluations on certain conditions, we do not recommend using Erchonia® non-thermal lasers on pregnant women, clients with a pacemaker, or clients with photosensitive epilepsy. We also do no recommend using our devices over an area of known cancer.
Will Erchonia® Lasers Cause Pain or Burning?
Erchonia® are true Non-Thermal Low-Level Lasers and cause no pain or health risks.
What Do Erchonia® Lasers Treat and How Are They Used?
Erchonia® lasers are used in many areas, such as 360-degree fat loss, body sculpting, cellulite reduction, pain management, pre / postsurgical healing, pre / rehabilitation, nail and skin pathologies (e.g. nail fungus and 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.
Why Choose Erchonia®?
With over 25 years of experience, 16,000+ devices in the market, and 20 FDA-clearances, Erchonia® Corporation are world leaders in medical-grade Photobiomodulation Therapy technology.
Erchonia® own 20 of the 23 FDA-clearances given to PBM Therapy devices, and the efficacy of our machines 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.
We are dedicated to producing safe, effective solutions designed for physicians, chiropractors, physical therapists, podiatrists, osteopaths, aesthetics clinics, veterinarians, and many other types of medical / health professionals.
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. Read More