• FDA Clearance
• Specifications
• What it is
• What it does
• How It Works
• Applications
• Contraindications
• Why 830 Nanometers?
• Compared to other Lasers
• Compared to LED Therapy

FDA Clearance

The MicrolightLaser® therapeutic laser system, utilizing the battery powered model ML-830 device and the 110 AC powered model ML-830 DC device, has received FDA clearance for a wide range of medical uses. These include:

• Relief of hand and wrist pain associated with carpal tunnel syndrome.
  
• Relief of muscle and joint pain.
  
• Arthritis
  
• Muscle spasm
  
• Relief of stiffness
  
• Promotion of muscle relaxation

Specifications

What it is

The MicrolightLaser® is a handheld, battery-operated, noninvasive, light-emitting, medical device. Approved by the FDA for sale and use in the treatment of a variety of soft and connective tissue disorders as well as certain neurological disorders, this device is a low energy laser also known as a “cold laser.” In contrast to general surgical or cosmetic lasers that produce heat and thermo-destructive laser energy, Low Level Laser Therapy (LLLT) produces no harm to human tissue in normal use and thus is classified by the FDA as a Class IIIB medical device. Cold lasers used in LLLT have been in medical use for over 30 years and have a long record of successful clinical studies demonstrating medical efficacy and safety. The MicrolightLaser®produces infrared (invisible) laser light at the 830 nm wavelength via three LASER diodes. A fourth visible LED (Light-Emitting Diode) is used to provide a visible red target light field for the clinician to target the desired tissue area. As a noninvasive contact medical device, the MicrolightLaser® is completely portable, very easy to operate and provides reliable and effective treatment options to the clinician and patient.

What it does

Through the action of photo-stimulation of light reactive biological receptors (chromophores) in the body, Low Level Laser Therapy (LLLT) has demonstrated the ability to significantly accelerate and enhance the body’s natural defense and repair components in the presence of injury, inflammation and certain disease processes. By modifying the effects and limiting the duration of inflammation as well as enhancing specific repair and healing processes, LLLT is consistent in providing pain relief, reducing injury damage and loss of function, in addition to facilitating more rapid repair and stronger healed tissue structures. Multiple clinical studies have noted the following results of LLLT:

• Increased collagen production
  
• Enhanced nerve regeneration
  
• Increased vasodilation
  
• Reduced inflammatory duration
  
• Increased cell metabolism
  
• Increased pain threshold
  
• Increased cell membrane potential
  
• Reduced edema magnitude
  
• Increased microcirculation
  
• Increased tissue and bone repair
  
• Increased lymphatic response
  
• Increased enzyme response

How It Works

As the light receptive chromophores in various tissues, in both cellular and sub-cellular locations, are irradiated with coherent laser light, energy transfers occur that stimula more active levels of function and increased interaction. Laser light, penetrating much deeper than other light wave forms, activates increased mitochondrial ATP synthesis, produces increased mast cell inflammatory mitigation and stimulates increased Ca2+ ion presence and beneficial reactive oxygen species (ROS) production.
Through the action of photo bio-stimulation, oxidative metabolism is increased via cytochrome C oxidase and photosensitization of hemoglobin. Laser irradiation stimulates increased endorphin release and increased prostaglandin synthesis. Due to the powerful effect photo-stimulated enzymes exert, both localized and systemic cascade reactions occur that result in immunomodulation and inflammatory mitigation. Damaged skeletal, connective and neurological tissues and structures react with enhanced healing in the presence of low level laser irradiation as collagen synthesis and production, satellite cell presence and cellular metabolism are increased as a result of the light stimulation and improved vascular, lymphatic and enzymatic activity.

Applications

Inflammatory conditions

• Rheumatoid Arthritis
  
• Carpal Tunnel Syndrome
  
• Epichondylitis
  
• Plantar fasciitis
  
• Bursitis

Pain Management

• Fibromyalgia
  
• Myofascial Pain
  
• Cervical neck pain
  
• Low back pain

Connective Tissue Injury / Disorders

• Sprains
  
• Strains
  
• Tendonitis
  
• Tendon ruptures

Joint Injuries / Disorders

• TMJ disorders
  
• Osteo Arthritis
  
• Dislocations
  
• Ligament Injury

Muscle injury / Disorders

• Muscle bruises, contusions
  
• Muscle ruptures
  
• Muscle contractures
  
• Myositis

Neurological injury / disorders

• Prolapsed disk
  
• Ruptured disk
  
• Crush injuries
  
• Neuritis

Skin injuries / conditions

• Surgical incisions
  
• Skin ulcers
  
• Burns
  
• Skin grafts

Contraindications

One of the unique features of LLLT is that there are very few true contraindications. This means that the therapy can be used in a wide variety of applications and conditions.

1. THYROID GLAND – While research results have been at odds, the current consensus is to avoid LLLT irradiation over the area of the thyroid gland.
2. PREGNANCY – Prudent medical care dictates that LLLT not be performed over the uterus of a known pregnant woman.
3. KNOWN CANCER TUMOR – Although the research is again at odds in this case, the recommendation is to not irradiate over or near a known primary or secondary carcinoma lesion or tumor.
4. RADIATION THERAPY PATIENT – Because LLLT has been documented to have an effect on the human immune system, in patients taking immunosuppressant medications, LLLT is not recommended at this time. Several studies have demonstrated positive effects of LLLT in counteracting radiation therapy nausea; however, more research is needed.
5. TREATMENT OF OVERSYMPATHETIC GANGLIA –The vagus nerves and cardiac regions of patients with known heart disease are not recommended for LLLT.

- ALLEGED CONTRAINDICATIONS -

1. PACEMAKERS – While some have suggested caution in using LLLT in the presence of pacemakers, no evidence has been presented. Because LLLT uses light, no influence on the pacemaker results from its use.
2. EPILEPSY – Pulsed visible light can have an effect on certain individuals susceptible to this condition, however, invisible, non-pulsed laser light (as is provided by the ML-830) has had no reported detrimental effect on seizure-susceptible patients.
3. DIABETICS – While this has been suggested as a contraindication, no evidence has been found to show that LLLT could aggravate symptoms. In fact several studies have shown dramatic improvement in healing of wounds of diabetics with LLLT.
4. CHILDREN – The concerns originally expressed for use of LLLT near growth plates in children have been found to be unwarranted. No detrimental bone growth effect has been documented, and in fact, LLLT in children has been found to be beneficial in pediatric fractures.

- GENERAL PRECAUTIONS -

Because the ML-830 laser emits invisible infrared light, use of it in the area of the face and around the eyes must proceed with appropriate care and caution. Invisible infrared laser light penetrating the eye may cause serious harm after extended exposure. Therefore, the use of the provided protective glasses for the patient and clinician is advised.

Why 830 Nanometers?

830nm-Greatest Depth of Tissue Penetration

When evaluating the sometimes confusing and varied choices in low level lasers, the question is frequently asked, "Why is the 830nm wavelength better?". The answer to this question is essentially one of penetration and delivered energy. In the treatment of soft and connective tissue injuries and disorders, the goal is to deliver the most effective laser wavelength to the target tissue.

Some 30+ years of scientific study and clinical research has provided us with detailed information on the reaction of biologic organelles to laser light. It has also shown us which wavelengths penetrate most deeply and what energy levels effect biological processes in the most desirable manner. We need to fully understand the relationship between the depth (from the skin surface) of the target tissue and the ability of the therapeutic laser light to reach that tissue.

We now have ample clinical evidence that in contrast to other wavelengths, the 830 nm laser light produces specific beneficial biological reactions that are not produced by other wavelengths. This unique ability to stimulate greater response is the key to 830nm laser therapy.

The light from the laser distributes in the tissue in the shape of a ball or an egg . This is dependent on the wavelength of the light. Short wavelengths give a smaller and fairly round ball-shaped distribution, while longer wavelengths give a more eggshaped distribution. The shorter 632 nm (HeNe) visible red wavelength, shown here in red, is more readily absorbed by blood and skin surface components, thereby limiting its tissue penetration.

The longer 830nm (GaAlAs) invisible infrared wavelength, shown in yellow, is not as readily absorbed therefore it has significantly greater depth of penetration. A greater amount of photons are delivered to the target tissue with the 830nm wavelength.

830nm Laser Results in Increased Endorphins

It is also important to note that this study confirmed that the 30mW power output provides better results than the low power, 5-10 mW units in endorphin stimulation.

Clinical studies done by Dr. Laakso et al from Royal Brisbane Hospital in Australia have confirmed that significant increases in plasma levels of endorphins resulted from 830nm laser irradiation. This same study showed that low dose diation do not result in significant increases in endorphin levels.

The ability of the 830nm wavelength to stimulate the production of pain reducing plasma endorphin levels, while other wavelengths did not, is important when clinicians are treating painful conditions.

Stimulates Increased ATP Production

Laser therapy has been used by leading scientists and clinicians around the world for over 20 years. In Japan, where laser therapy is considered a preferred medical practice, Dr. Noriko Mochizuki et al published a clinical study on the effect of laser therapy and ATP production.

In that study, the scientists found that tissue levels of ATP were significantly increased when the target area was irradiated with 830nm wavelength laser light. The study further stated that this beneficial increase in ATP production was not the result of temperature modification, but rather a direct response to the effect of laser light photons.

This study also showed that while 830 nm wavelength laser light stimulated ATP increases, laser light at 632nm had no stimulatory effect on ATP production.

This study along with a host of other clinical reports confirm the singular ability of the 830nm laser wavelength to stimulate cellular responses that result in accelerated metabolism and repair.

Since ATP functions as the primary fuel for cellular activity, stimulated increases of this energy source greatly enhances cellular ability to perform and complete biological processes.

Provides Optimum Photon Level

One of the major contributors to the effectiveness of low level laser therapy is the exchange of energy from light photons to the biological receptor.

In order to achieve any therapeutically significant response, there has to be sufficient photons delivered to the target tissue.

The availability of photons for stimulation is a function of both the appropriate wavelength and device power output.

These two factors determine the amount of photons reaching the desired location.

In treating conditions of greater than 1 cm in depth from the skin surface, the combination of the 830nm wavelength with a 30mW output produces the optimum photon beam.

Devices using other wavelengths and the very low 5-10 mW output lack the capability to supply adequate photon energy to deep tissue conditions.

Compare Wavelength Characteristics

While the 632 nm wavelength is limited to a tissue penetration of approximately 1 cm, the 830 nm wavelength has been documented with tissue penetrations of 3-4 cm or greater.

With more than twice the penetration of the shorter 632 nm (HeNe) laser wavelength, the 830nm (GaAlAs) medical laser has the ability to provide healing therapy to damaged and injured cellular components in addition to enhancing the ability of circulatory and lymphatic systems to achieve maximum benefit.

Tendons, ligaments and muscle tissues that lie beyond the reach of the shorter wavelengths can be treated with the 830nm laser due to its unique deeper penetration characteristics.

Just as effective for surface conditions as other wavelengths, only the 830 nm wavelength can realistically treat deep tissue conditions.

The Long And Short Of It

Laser wavelengths below 800nm and above 850 nm quickly decrease in penetration and absorption capabilities.

Since we know that the target structures or tissues for most treatment modalities are deeper than just the superficial skin and subcutaneous tissue, the ideal wavelength is one that can penetrate beyond surface layers.

As seen in the illustration on the right, the longer (830nm) wavelength has both deeper light penetration and a different light absorption characteristic that enables it to deliver the needed laser light concentration to accelerate cellular functions and healing.

Studies conducted over 15 years and reported in over 100 clinical reports show the 830nm laser wavelength to be the most effective in therapeutic applications.

Absorption, Penetration, Power—They Are The Keys

Studies such as this absorption graph have been conducted and demonstrate that wavelengths above and below 830 nm are absorbed more and penetrate less.

The more of the laser light that is absorbed in the surface layers of the skin and tissue, the less energy there is to be transmitted to the deeper layers of tissue and structures.

As was found in this study, the 830nm wavelength has the least surface absorption, and therefore the deepest penetration and best effect.

In the final analysis, the clinical evidence and laser science is strongly in favor of the 830nm GaAlAS wavelength as the most appropriate wavelength for therapy involving deep tissues.

The other factor to consider is the power output of the device. While very low power output devices (510mW) can have therapeutic effect on surface or shallow tissue, the time needed for such low power devices to effect deeper tissue is impractical for therapy session.

The combination of the 830nm wavelength and a 30mW power output allows for deep photon penetration and reasonable time frames to deliver the needed energy dosage to the target tissue.

Longer (830nm) Wavelength Effective For Deep Pain Where Shorter Wavelengths Are Not Recommended Nor Effective.

The other issue in regards to wavelength is the capacity to deliver the necessary energy to the target tissue. While nearly all low level medical laser wavelengths can deliver some energy to surface tissue, therapeutic dosage of light energy to deep lying tissue cannot be accomplished with short wavelengths.

This chart from a leading medical laser textbook demonstrates that short (HeNe, InGaAlP) wavelengths are inappropriate for deep lying pain because such short wavelengths simply cannot reach the target tissue.

The 830nm (GaAlAs) wavelength is the most therapeutically effective wavelength for deep lying pain and healing deep tissue.
PLASMA ACTH AND b -ENDORPHIN LEVELS IN RESPONSE TO LOW LEVEL LASER THERAPY (LLLT) FOR MYOFASCIAL TRIGGER POINTS Laakso et al Royal Brisbane hospital, Australia

EFFECT OF POWER OUTPUT AND ENERGY DENSITY— ABSTRACT EXCERPT

(1 J/cm2 and 5 J/cm2) of an infrared (JR) laser (820 nm), a visible red laser (670 nm) and a near-monochromatic light emitting device (660 nm, 30 nm bandwidth). ACTH was shown to have a cumulative response to treatment with 1 J/cm2 infrared laser (p < 0.001) and 5 J/cm2 red laser (p < 0.05) responding significantly.. b -endorphin was noted to be significantly elevated between days one and four (p < 0.05) in subjects who received IR (5 J/cm2) laser. Results indicated that the analgesic response to phototherapy may be mediated through hormonal/opioid mechanisms, and that responses to LLLT are dose and wavelength dependent, that is, there may not have been sufficient photonic energy to stimulate responses using 660 nm nearmonochromatic red light or low dose 670 nm (red) laser.

CONCLUSIONS

This study has confirmed that responses to LLLT are dose, power output and wavelength-dependent.. High dose (5 J/cm2) IR laser resulted in increases in plasma b -endorphin levels over the duration of the study suggests that localised, peripheral phototherapy of trigger points can induce cumulative activation of central hormonal /opioid pathways capable of regulating immune function. It is acknowledged that power density may have resulted in the fact that neither low dose nor high dose nearmonochromatic red light (660 nm) was found to be capable of eliciting significant changes in blood biochemistry.

Compared to other Lasers

NOT ALL LASERS ARE THE SAME.

Just because the product or device is marketed as a medical laser does not necessarily mean it is either the most effective or appropriate for the widest possible variety of medical conditions. MicrolightLaser®’s patented combination of the 830nm wavelength and 30mW laser output makes this device unique in its ability to provide the most effective and efficient therapy.

Laser devices using wavelengths below 810nm or above 860nm are compromised in their ability to deliver maximum photon energy to the greatest tissue depth. When treating deep pain or deep tissue injury or disease, the 830nm wavelength has been shown to have superior ability to effect relief and healing.

Multiple studies have shown that the 830nm wavelength is capable of stimulating increases in ATP production and pain relieving b-endorphins where other wavelengths were unable to stimulate these increases.

Clinical evidence is abundant regarding the diminished simulative capability for devices with very low power output (10mW or less) as well as devices with excessive power outputs (100mW or greater). The most effective therapeutic window in terms of power output has been clinically demonstrated to be optimal at the 90mW threshold. The MicrolightLaser® device combines three 30mW laser diodes to produce this optimal 90mW delivered energy capacity.

We also believe it is important to provide a reliable and durable medical device to customers. Rather than use plastic or other less durable construction components, MicrolightLaser® is constructed of high-grade but lightweight metal. This has proven to be a superior material and allowed us to offer the strongest and most durable device while still maintaining a very lightweight and user-friendly device. Other laser devices made of plastic and similar materials are more prone to breakage and failure.

Compared to LED Therapy

Not all light is the same and not all monochromatic light is the same or has equal medical benefit. Recently, controversy has arisen over the comparison of true laser light in low power therapy as contrasted with LED (Light Emitting Diodes). It is very important that the distinctions between the two and their completely different biological effects be accurately portrayed. Today there are a number of devices and therapies available that use LED’s and super luminescent LED’s (SLLED’s) as the light emitting components for their therapies. Some of these are even advertised and promoted as lasers, which they are not. So, in order to set the record straight and to provide meaningful and accurate comparisons, let’s explore these two light sources in a scientific approach.

Of the hundreds of referenced and reported clinical and scientific studies and papers available, they are almost exclusively done with laser light sources as the medically beneficial light source. In fact, even on the web sites of the leading LED light devices, the sources and references they list are not for LED therapy, but rather for laser light therapy. Manufacturers of such devices as Bioflex, Anodyne and the Dynatron Solaris units, which are LED therapy devices, primarily use laser light studies as their medical efficacy support.

A number of studies have been completed that compared the effectiveness of laser light to LED light and the majority have found laser light to be far more effective, particularly in treating tissue of any significant depth. While LED light therapy does have some beneficial effect, it is limited to superficial tissue treatment only.