A medical device is FDA cleared for an indication. This is also referred to as a 510k Submission or PMA Submission and allows the device manufacturer to make specific claims that inform the general public of what the product can provide in terms of a treatment outcome. In the 510k Submission, the device must prove that it is substantially equivalent to a predicate device (an existing cleared technology) and the manufacturer has to provide results of a clinical study to prove efficacy. Attaining a clearance also means the device has been fully tested by an independent testing facility to verify it meets multiple requirements as stipulated by the FDA, 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 (see FDA Approved below) and “FDA Registered” does not mean the device has been cleared by the FDA (see FDA Registered below). An FDA Registered device manufacturer cannot make any claims about treatment outcomes without having an FDA Clearance for specific indications.
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.
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.
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.
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 a 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.\
The first 635nm LLLT device was released with a lot of fanfare and promoted as a quick-fix fat reduction device, even without FDA approval of those claims. Since it was laser-based, it was primarily sold to physicians, but the level of training and education was less than satisfactory to the point where most physicians did not understand the entire process. As a result, patients were over promised and most experienced less than acceptable outcomes. Patients expected to just sit under the light and their fat would be melted away, but that’s not how 635nm LLLT works. It was not properly stressed with the patients that the right diet, a slight amount of exercise to stimulate the lymphatic system and drinking plenty of water will dramatically improve their results. Additionally, the fact that the 635nm light source on this device was very weak, was positioned away from the patient’s body (measured light energy dissipates at an exponential rate as the distance between the source and the target increases), plus the beam was moving and not focusing on one specific spot, creating a situation where very little light energy was delivered to the fat cells. Since that early version, studies have been performed and a better understanding of the complete process with the steps that need to be taken to attain acceptable results has helped this segment of the market evolve into a proven and successful revenue-generating technology.
LLLT stands for Low Level Light Therapy. This is different from 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 an immediate response. LLLT devices are much safer to operate as compared to medical or aesthetic laser systems.
Yes. The light emitted by these devices 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 is much safer than a laser device that can damage eyes with even a slight glance into the beam.
The label of 635nm refers to the wavelength of light the device produces.
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).
The recommended 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 1st treatment. The full series of 10 treatments should address most patient expectations, but some patients may want to continue with additional treatments.
These treatments are 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.
Any part of the body is able to be treated; hips, waist, thighs, back, upper arms and neck.
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.
To achieve optimal results with the red light therapy treatments, 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.