Has the FDA reviewed Healthlight or other Infrared systems?
The Healthlight Infrared System and many other infrared therapy products are recognized by the FDA under classification (IRT) 890.5740 (infrared heating pad). Other infrared devices maybe classified as "heating lamps" or "heating pads".
Please keep in mind that currently the FDA DOES NOT APPROVE ANY infrared photo energy therapy device specifically to treat neuropathy. Any company that claims this is being false and misleading.
What is the difference between an LED and a low level laser?
Both contain diodes (a little light with two wires connected to a filament inside) that can be made of the same materials, usually silicon with specific minerals added in specific amounts to produce different colors.
In lasers the diode is mounted in a well shaped area (like a small tin can with one end removed) that is lined with reflective material that sends on only one wavelength of light. The result is a narrow beam of light that is concentrated into a beam, referred to as "coherent" light. However, when using low power levels (soft lasers) the light energy does not remain coherent and scatters when it hits the skin. This is given as the explanation why LEDs and low level laser devices have similar healing effects. The source of this information is found in studies from the Russian Academy of Sciences published in the journal Health Physics. LED products have an advantage in price being far more economical.
What is Infrared or Light Therapy?
Light therapy is currently being used in clinical and home settings around the globe. Light therapy has been in use by the medical profession for more than 20 years, to reduce pain and increase circulation. Its growing acceptance has become more abundant in the medical field.
This acceptance has brought about much change in the use of LED's (Light Emitting Diodes). Also called Monochromatic Infrared Energy, the uses are many. The potential of this technology was realized in the veterinary discipline when many disorders were easily corrected using these LED's. Since these uses became a more common practice, the medical community then began research. Many were immediately realizing the positive effects and potential life saving qualities allowing these Doctors and Therapists to effectively treat many conditions. Many of these conditions have been corrected with dangerous drugs and ineffective surgeries.
How is light energy measured?
Light energy is measured in joules, the energy that is generated when 1 watt of power flows for 1 second. It takes only 1 joule of energy to activate an acupuncture point.
What are some of the differences between the Healthlight and more well known infrared therapy products?
Some infrared therapy devices utilize technology that is several years old. They may use monochromatic non-visible infrared light energy diodes that get very hot. Small pads (4 1/4” by 2 1/4”) with limited flexibility, or are non-pad wand type devices. These devices may release infrared energy at varying nanometers of output and minimal milliwatts of power per diode.
The Healthlight System, which has been available almost 3 years, uses a newer combination of non-visible and visible infrared light energy to promote regeneration and revascularization of damaged capillaries by releasing excess nitric oxide from cells.Healthlight’s unique visible light feature (640nm), which can penetrate 8-10mm, is very beneficial in treating problems close to the skin surface. These include wounds, cuts, scars, trigger and acupuncture points. Visible light is also particularly effective in treating infections.
The Invisible Infrared light (880nm) has been shown in studies that it can penetrate to a depth of about 30-40 mm. This makes it more effective for bones, joints, deep muscles, etc. Although both red and infrared wavelengths penetrate to different depths and affect tissues differently, their therapeutic effects are similar.
Healthlight’s pads measure about (5 x 8) for the Universal pad, and about (6 x 8 x 24) for the Boot pad are made of soft flexible Neoprene and are more than twice the size as our competitor’s therapy pads. Healthlight’s diodes release infrared light at approximately 880 nanometers.
Any system with 880nm or more of invisible light is preferable, because of the depth of penetration and high absorption because photo energy to be effective must be absorbed by the target tissue. Since the photo energy (light) is infrared, it cannot be seen. Some therapy system’s average energy emitted from the diodes is about 10-13 milliwatts per square centimeter. The Healthlight emits an impressive 100 milliwatts of energy per diode.
What colors of LEDs work the best?
Red has been used in light therapy for hundreds of years shining sunlight on the bare skin through stained glass. Probably more is known about treatment with red wavelengths than other colors. Research in Russia found biologic effects are most active with wavelengths around 440, 630 to 660, and 880 nanometers, corresponding to blue, red, and infrared (beyond what humans can see). Red seems to stimulate the system, blue to sedate. In recent studies blue light from LEDs has been effective in treating jaundice of the newborn, and a specific wavelength of blue light in treating acne. Other colors may have additional indications, especially when used on specific areas of the body.
What happens when the Healthlight Therapy unit is used?
Healthlight's array of infrared and visible light diodes creates a comforting warm feeling under the pads. The photo energy (pad heat) dilates the blood under the vessels, which often causes an increase in circulation. The light and mild warmth from the Healthlight also may reduce and alleviate pain. Additionally, patients may experience a decrease in
local swelling, decreased inflammation, decreased muscle spasms and tightness, and decreased tension, increased range of motion, increased lymphatic drainage and increased venous dilation and flow. Diabetic patients with peripheral neuropathy typically may experience an increase in sensation to pressure and hot/cold.
Why are Healthlight's products pulsed to Nogier's frequencies?
Pulsed devices are more effective than non-pulsed, and those pulsed to the tissue resonance frequencies of Nogier were the most effective. This confirmed the conclusions of veterinary acupuncturists who have been using such devices since 1982. We concur with them that specific wavelengths (color) may be important in specific conditions (as in the acne light), but that pulsing light at Nogier frequencies seems to be more important than wavelength (color) in the healing response for most conditions.
How did Nogier discover his tissue resonance frequencies?
Dr. Nogier discovered a new radial pulse that is very different than the 12 Chinese pulses. He felt the radial artery with the tip of his thumb, then held things he wanted to test in his free hand and approached the ear. When the energy field of the body is responding to something, subtle characteristics of the pulse change. In one avenue of his work he tested photographic filters of different colors. Lastly he broadcast different frequencies at parts of the body to see how the pulse changed. He gradually found a pattern of responses to frequencies that corresponded to the early embryonic origin of tissues (ectoderm, endoderm, or mesoderm). Although Nogier tested only humans these resonance frequencies later were found to apply to all animals. His reflex test was so sensitive he could accurately tell when a woman was pregnant only 10 days after conception. He also demonstrated to students how the system could diagnosis cancer in its earliest stages (even the stage in which it is nothing more than an electrical disturbance) by using glass slides containing tissue from ground up cancers (confirmed later with standard tests).
What is the most impressive story you have heard using light for healing?
Healthlight has heard great feedback and stories from many patients and clinicians. However, a case described in a Spanish laser journal. A man had chronic infections in both tibias for 40 years (osteomyelitis-the most dreaded infection for orthopedic surgeons). An all out effort was made to clear up the right leg ending with a skin graft that was automatically treated with low-level laser therapy (remember, this was in Europe, not the US). On the left side he had an even more devastating problem with a draining fistula tract connecting the bone infection with the skin. After 10 weeks of light therapy on the right leg the osteomyelitis and fistula in the untreated left leg healed completely!
How does the Healthlight Therapy reduce pain and increase circulation?
The infrared photo energy releases nitric oxide from the hemoglobin and possibly surrounding tissue. Nitric oxide is a signaling molecule that is known to relax smooth muscle cells found in the arteries, veins, capillaries and lymph vessels. When these muscles relax, they dilate the blood vessel, thus allowing increased circulation. Nitric oxide has been shown to be essential for wound healing even if chronic or traumatic. Scientific literature shows that nitric oxide promotes collagen synthesis, collagen fibril alignment, and angiogenesis. Nitric oxide is also a neurotransmitter. Please see our link about nitrous oxide.
Have increases in circulation associated with infrared devices ever been measured?
Yes. Tests have been conducted with a scientific instrument known as a scanning laser Doppler, which measures circulation at 1 to 2 millimeters (microcirculation). These tests demonstrate increases from 400% to 3200% after just a treatment. Please note that comparative increases in circulation using heat or ultra sound are substantially less than those observed with the leading infrared systems.
Are there any known adverse side effects with using infrared therapy?
If used with manufacturer’s instructions for use the Healthlight is very safe. The manufacturer, (for liability reasons, does not recommend its use where there is an active malignancy or for patients who are pregnant since other modalities are likewise not recommended in these situations.
Note 1: diabetic patients should closely monitor their insulin levels during treatment as some patients require less insulin and may need to adjust their insulin dosage to prevent hypoglycemia.
Note 2: Some infrared systems may burn the skin if left on too long. This is not an issue with the Healthlight. The Healthlight also has a built in timers and auto shut-off feature.
What is the story with Medicare coverage of home infrared units, its all confusing?
Quite simply, Medicare currently does not approve the E0221 Code (Infrared Heating Pad) as a covered item for home treatment. Most insurance companies follow this policy.
It is common knowledge Medicare will cover and regularly reimburse wheelchairs, oxygen, beds, etc. under specific codes. You can obviously get these devices at most local medical supply stores, and the stores will bill Medicare or insurance for you. If home infrared therapy devices were approved, most medical supply stores would be happy to sell and bill them for you. Since they are not reimbursed, medical supply stores don't offer them.
Since, Medicare doesn't normally approve this E0221 code, any supplier telling you its "covered by Medicare" is false according to Medicare. If a supplier decides to submit your claim to Medicare the claim will automatically be declined. Period.
What happens when the supplier's claim is denied by Medicare ?
All denied Medicare claims must be appealed to a Medicare administrative law judge. This appeal process may be 1-2 years. After all appeals, there is still no guarantee of approval. It is up to the individual supplier if they want to do this.
Please review our Medicare information web pages and/or call your local Medicare office to clarify this.
Do home infrared therapy devices require a prescription from a physician?
No. Most infrared devices such as Healthlight do not require a prescription. Anyone may purchase a system without prescription, or having had treatments at a facility.
However, if you wish to receive treatments at a clinic with infrared therapy, your insurance or Medicare usually requires a prescription or referral to the facility in order to be reimbursed under your health plan. This is completely separate issue from coverage of the home units.
