Contour Light System | FDA-Cleared Red Light Therapy Machine

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 for an extended period of time, but it is much safer than a laser device — which can damage eyes with even a slight glance into the beam.

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 during the session, and some even take a short nap.

The recommended Contour Light® treatment protocol involves 10 treatments in a series, delivered every other day or every 3 days. Most patients see a noticeable improvement within the first 2 or 3 treatments — some as early as the very first session. The full series of 10 treatments should address most patient expectations, and some patients continue with additional treatments for maintenance or refinement.

Results will vary from patient to patient, primarily depending on the patient's commitment to their own goals. If a patient maintains a healthy lifestyle — including a diet and exercise program that supports weight control — their results can be long-term.

The Contour Light® can be used on any part of the body, including the hips, waist, thighs, back, upper arms, and neck.

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 always recommended to consult their physician before starting any diet or exercise program that accompanies treatment.

Clinically obese patients can benefit from treatment involving a 635nm device. Just as with any patient, the improvement in appearance often has a motivating effect, encouraging the patient to apply consistent effort that can produce exceptional results over the long term.

To achieve optimal results with the Contour Light® treatments, the patient should follow the simple steps outlined in our protocol. This 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.

No. There is no evidence that a 635nm treatment will cause an elevation of triglyceride or cholesterol levels. These treatments are completely safe.

The label of 635nm refers to the specific wavelength of light the device produces. This particular wavelength is clinically associated with the biological effects that make red light therapy effective for body contouring and circulation.

LLLT stands for Low Level Light Therapy. It differs from medical or aesthetic laser treatments because the energy emitted by an LLLT device is much lower than that of a medical or aesthetic laser system. The effects on the patient's skin with an LLLT device are gradual, as compared with a medical or aesthetic laser that delivers an immediate response. As a result, LLLT devices are much safer to operate.

The light emitted by a 635nm device — regardless of whether the source is laser-based or LED-based — delivers the same reaction within the tissue. This has been demonstrated in a study conducted by a physician showing that both types of light became diffused upon entering the dermis. The light was diffused to the point where there was no negligible difference between the two types by the time it reached the subcutaneous fat cells (fat cells below the surface of the skin).

Yes. There are many versions of 635nm devices on the market. Some are classified as medical devices because 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 — such as the Contour Light® — will not cause injury to patients or technicians, so they are much safer to operate.

A medical device is FDA cleared for a specific indication — also referred to as a 510(k) Submission or PMA Submission. This clearance allows the device manufacturer to make specific claims about what the product provides in terms of treatment outcomes.

In a 510(k) Submission, the device must prove that it is substantially equivalent to a predicate device (an existing cleared technology), and the manufacturer must provide clinical study results to prove efficacy. Attaining clearance also means the device has been fully tested by an independent testing facility to verify it meets FDA requirements — including electrical functionality and safety under temperature and humidity conditions, plus numerous additional benchmarks.

Medical devices are not simply classified as "FDA Approved" but must be cleared for a specific indication. And "FDA Registered" does not mean the device has been cleared by the FDA. An FDA Registered manufacturer cannot make any claims about treatment outcomes without having an FDA clearance for specific indications.

"FDA Approved" is a designation reserved primarily for drugs and devices that can cause serious harm if used incorrectly, as well as similar products required to demonstrate safety and efficacy through the FDA Approval process before being sold as a remedy for illnesses or diseases (whether prescription or over-the-counter).

Medical devices can be FDA Cleared, but they are not simply labeled as "FDA Approved" without having a clearance for a specific indication. Any entity that claims a medical device is "FDA Approved" but cannot provide either their 510(k) Number (a 7-character number starting with "K" followed by 6 digits) or their "P" Number (PMA, similar format but starting with "P") is attempting to mislead the public.

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 about treatment outcomes.

If a manufacturer makes such claims while only being FDA Registered, they would be in violation of FDA regulations. Making such claims is against the law and could result in the temporary or permanent shutdown of the business and even incarceration of the business owners. Purchasing a device from a company with a history of making claims without an FDA clearance could result in the buyer having no recourse for returns and no support for future repairs or supplies.

An IRB is an independent board that reviews, approves, and authorizes studies involving human test subjects. The FDA generally requires any clinical study submitted with a 510(k) application to have been reviewed by an IRB.

Any study published by a manufacturer and released to the general public should first be approved by an IRB. If it is not IRB approved, the study should be considered invalid and potentially inaccurate or biased. The Contour Light® clinical study — showing an average of 2.49" lost per session across 118 participants — is IRB-approved and registered on clinicaltrials.gov (#NCT04451824).