The concept of laser light
A laser is an optical device that emits light through a process of optical amplification based on the stimulated emission of electromagnetic radiation.
LASER is an acronym for “Light Amplification by Stimulated Emission of Radiation”.
A laser differs from other sources of light because it exhibits some special properties like; coherence, monochromatic, directionality, and high intensity.
since the invention of laser in 1960 by Theodore Harold.
laser has been widely applied in many fields of medicine. An example is the musculoskeletal healing process of Low-Level Laser Light Therapy(LLLT). Due to its ability to generate single wave-length.
Low-Level Laser Therepy(LLLT)
Low-level laser therapy is a form of medical treatment that applies low-level lasers light or light-emitting diodes to the surface of the body. It is also called photobiology or biostimulation.
Due to its ability to produce single wave-length. It’s a non-invasive source of treatment for musculoskeletal pathologies. Low-Level Laser Light(LLLT) emits no heat, sound, or vibration.
How Effective is Low-Level Laser Therapy(LLLT)
Studies have shown that the use is Low-Level Laser in the treatment of neck pain, tendinopathy, and possibly, chronic joint disorders can be considered moderately effective. (LLLT) affects the function of connective tissue cells (fibroblasts). Accelerate connective tissue repair and act as an anti-inflammatory agent. Lasers with different wavelengths. Varying from 632 to 904 nm applies in the treatment of musculoskeletal disorders
Whereas high-power lasers apply in medicine to cut or destroy tissue. That the application of low-power lasers relieves pain or stimulates and improves cell function.
Is Low-Level Laser Therapy FDA Approved?
The question is often asked; is this low level laser approved by the Food and Drug Administration (FDA) which began regulating medical devices including low level lasers in the late 1980s. Technically, the FDA does not approve lasers.
The first step for any company that wants to sell lasers is to register the instrument for safety. The FDA determines safety by the potential for risk to the human eye at 20 centimeters. An important feature in classifying lasers depends on whether the laser is culminated – that is the beam comes to a point, or if the beam is linear and dissipates as the laser is moved further away. Following is a simplified explanation of the five laser classifications:4
Class 1 is a laser that will not cause harm regardless of length of exposure and is considered a non-significant risk device. An example of this is the laser in bar code check out systems.
Class 2 is a low power visible light laser (<1mW) that may cause damage to a person’s eyes if exposed for a long period of time. Examples are some laser pointers and range finding equipment.
Class 3a is continuous wave laser (1-5 mW) that can cause harm to the eyes if exposed for a long enough period of time. Examples are laser pointers and laser scanners. This class of laser shouldn’t direct to the eyes.
Class 4 is an intermediate power laser (5-500 mW or pulsed 10 J/cm² ). Uses are spectrometry and entertainment light shows. Direct viewing, or even diffuse reflections of the beam, will cause harm to the human eye and protective eyewear should be worn.
Class 5 are high power cutting lasers (>500mW or pulsed >10J/cm²). The direct beam and diffuse reflections are harmful to eyes and skin. Protective measures should be taken. Lasik eye surgical lasers are an example of this type of laser.
FDA assigns accession numbers to low-level laser instruments which are under registration for proper identification. After the registration, instruments for human use the direction of an Investigational Review Board (IRB) or used as a veterinary laser.
Second Step For Complete Registration
The second step is to complete clinical trials under the direction of an IRB and apply for the FDA for pre-market clearance. However, on getting the pre-market clearance, the company may make claims that their laser can treat the condition that was studied in the clinical trials.
Please note that getting pre-market clearance is not a guarantee that the laser is use to treat anything. Though some companies take the freedon of clearance to advertise beyound their clearance. But luckily the Federal Trade Commission regulates untruthful adverts.
Another way to get the FDA’s blessing to sell lasers is by applying for 510k clearance. This application requires less time and does not require clinical trials. A company submits an application with the claim that their laser has some of the exact same features as a previously-cleared device. While the 510k approach is much quicker, it has led to several lawsuits for patent violations.
Some lasers, cleared under the 510k using another laser company’s clinical trial, are no longer available due to the legal ramifications. There are currently over 35 different low-level laser instruments clear by the FDA, either by clinical trials or 510k applications. Many of the 510k clearances are based upon older heat-producing laser instruments on which the patents have expired. These companies often make claims that their laser treats anything that heat would treat.
However, Low-Level Laser contradicts treatment of the following illnesses;
- Eyes: Do not aim laser beams into the eyes and everyone present should wear appropriate safety spectacles.
- Cancer: Do not treat over the site of any known primary carcinoma. Or secondary metastasis unless the patient is undergoing chemotherapy. LLLT reduces side effects such as mucositis.
- Pregnancy: Do not treat directly over the developing fetus.
- Epileptics: Be aware that low frequency pulsed visible light (<30Hz) might trigger a seizure in photosensitive, epileptic patients.
For a clear and more detailed explanation of low-level laser therapy, please visit this page to learn more