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FDA - Approved
Drugs, devices that can cause serious harm and other similar products must be FDA approved in order to be sold as a remedy for illnesses or diseases, whether it is a prescription or over the counter item. Medical devices can be FDA Cleared, but are not simply labeled as "FDA Approved" in general without having a clearance for a specific indication. Any entity that claims a medical device is FDA Approved but cannot provide either their 510K Number (7-figure number, starting with "K" followed by 6 digits) or "P" Number (as in PMA and is similar to a K Number but begins with a "P") is attempting to mislead the public.
FDA - Registered
A company can apply with the FDA to be classified as "Registered". This simply means the company has notified the FDA of the types of products it produces. Being registered does not give the company the right to make any claims as to what it can provide in terms of treatment outcomes and, if making such claims when only FDA Registered, the company would be in violation of FDA regulations. Making such claims is against the law and could result in the temporary closing or permanent shut down of the business and incarceration of the business owners. Purchasing a device offered by a company that has a history of making claims without an FDA clearance could result in the buyer having no recourse in returning the product and no support for repairs or supplies in the future.
Can anyone be treated?
A Contour Light® treatment is safe and effective for anyone who does not have a medical condition that reduces their ability to eliminate waste via the liver and kidneys. Patients are recommended to consult their physician before starting any type of diet or exercise program.
What areas of the body can be treated?
The Contour Light® can be used on any part of the body; hips, waist, thighs, back, upper arms, and neck.
What can a person do to optimize their results?
To achieve optimal results with the Contour Light® treatment, the patient should follow the simple steps outlined in our protocol. This protocol involves a moderate diet, minimal exercise, and reasonable water consumption. Any individual who is committed to improving their appearance will have no problem following these guidelines.
Institutional Review Board. This entity is an independent board that reviews, approves and authorizes studies involving human test subjects. The FDA generally requires any clinical study that is submitted with a 510k application to have been reviewed by an IRB. Any study that is published by a manufacturer and released to the general public should first be approved by an IRB and if it is not IRB approved, the study should be considered invalid and potentially inaccurate or biased.
There are many versions of 635nm devices on the market, some are classified as a medical device due to the fact they are laser-based, while others are LED-based. Laser-based 635nm devices require physician oversight and cannot be operated by a non-medical technician without direct physician supervision. LED-based 635nm devices will not cause injury to patients or technicians, so they are much safer to operate.
Will a 635nm device work on an obese individual?
Clinically obese patients can benefit from a treatment involving a 635nm device. Just as with any other type of patient, the improvement in appearance has a motivating effect, enabling the patient to apply an effort that can provide exceptional results in the long term.
The patient will lie on a treatment bed and the pads are placed over the area to be treated. The system will be turned on and the patient will feel a slight warming sensation, but no pain or discomfort. Most patients can read or use their phone/portable device, while some will even take a short nap.
Results will vary from patient to patient, primarily due to the commitment by the patient to their goals. If a patient maintains an healthy lifestyle of a diet and exercise program that promotes weight control, their results can be long term.
There is no evidence that a 635nm treatment will cause an elevation of triglyceride or cholesterol levels. These treatments are totally safe.
Yes. The light emitted by the Contour Light ® does not generate excessive heat and will not cause a burn. The light is very bright and should not be looked at directly or an extended period of time but it is much safer than a laser device that can damage eyes with even a slight glance into the beam.
LLLT stand for Low Level Light Therapy. This is different than a medical or aesthetic laser treatment because the energy emitted by a LLLT device is much lower than a medical or aesthetic laser system. The effects on the patient's skin with a LLLT device are gradual, as compared with a medical or aesthetic laser that delivers and immediate response. LLLT devices are much safer to operate as compared to medical or aesthetic laser systems.
The label of 635nm refers to the wavelength of light the device produces.
What is the difference between laser light and LED light when it relates to this technology?
The light emitted by a 635nm device, regardless of whether the source is laser-based or LED-based, will deliver the same reaction within the tissue. This has been proven in a study done by a physician that indicated both types of light, laser and LED, became diffused upon entering the dermis. The light was diffused to the point where there was no negligible difference between the two types of light when it reached the subcutaneous fat cells (fat cells below the surface of the skin).
Feel Fuller Longer
Red Light helps suppress hunger-promoting hormones and increase levels of satiety - inducing hormones.
Increased Fat Loss
Contour Light literally melts your fat cells away. Watch the inches fall off each and every session.
Sleep Better
A study published in 2012 showed that people who received Red Light Therapy before bed reported increased sleep quality due to higher levels of melatonin.
Improved Healing
A study published in 2017 showed that Red Light Therapy can reduce inflammation, which causes cells to function normally and heal the body.
Discover A New YOU
Contour Light®'s revolutionary treatment helps you shape up your trouble spots by targeting fat deposits with light and heat. The light penetrates deep into the skin, stimulating the fat cells, and allowing them to release their stored triglycerides.
You can slip back into your old jeans once again by getting rid of the extra "fluff" with our Red Light therapy! The effects of Contour Light® treatments can provide long-lasting results, and you won't have to continually spend money on upkeep. Compared to other body contouring or fat-reduction technologies, it can help you achieve your desired outcome and maintain it for an extended period.
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