Does your practice have a Laser Safety Program? Does your staff conduct an annual laser safety audit to determine the level of compliance? It is never too late to set up and follow some basic guidelines.Continue reading
Laser therapy is being investigated as possible treatment both immediately following an injury and reducing the symptoms of individuals suffering from chronic concerns years after the injury occurred.Continue reading
Innovations in technology have allowed us to develop all sorts of medical devices that have revolutionized medicine. However, lots of these devices, when operated incorrectly, can cause serious harm to patients and the staff using them.Continue reading
Laser Therapy as an Alternative Treatment for Mouth & Jaw Pain
Have you ever met someone who actually likes going to the dentist? We haven’t either. But regular dental exams are necessary to maintain our oral health, and dentists can spot early warning signs of other serious diseases, like certain cancers, rheumatoid arthritis, lupus, or diabetes, from their examinations.
If you’re experiencing pain in your mouth or jaw, it’s time to make a call to the dentist. But not all dental treatments have to be painful and uncomfortable. Dentists can use laser therapy to help relieve pain and accelerate healing for common oral health issues.
Common Causes of Pain & Inflammation in the Mouth & Jaw
Pain and inflammation in the mouth and jaw is harder to ignore than pain in other areas of the body. Since we need our mouths to eat, breath, and talk, if something is awry—it won’t be ignored. Below are some of the common causes of mouth and jaw pain.
Impacted Wisdom Tooth
Your third molars usually start to come in around the age of 18, or the “age of wisdom.” Most people end up having some or all of their wisdom teeth removed because these wise teeth often grow in at an angle, causing them to push into other teeth instead of up through the gums and become “impacted.” Impacted wisdom teeth can cause pain in the back of the mouth and in the jaw. If they’re not removed, impacted wisdom teeth can become infected or cause damage to the teeth they push against as well as the lower jaw.
Bruxism is the clinical term for teeth grinding and jaw clenching. This condition is most common in children, and they usually grow out of it. However, people with sleep disorders like snoring or sleep apnea are at risk for bruxism as an adult. Untreated, bruxism can become extremely painful, causing a sore or even locked jaw and tension-like headaches. Additionally, the constant grinding at night can wear down and damage teeth.
Your temporomandibular joint (TMJ) is a sliding joint that connects your lower jaw to your skull. You can feel its movement if you set your hand on the side of your face, just in front of your ear, and open your mouth. Acute jaw injury, arthritis, genetic factors, and bruxism can cause inflammation of the cartilage disc between the bones in this joint, leading to pain and restricted movement of the jaw as well as an aching in or near the ear (however the ear itself is not affected).
Peri-implantitis is the inflammation of soft tissue that causes the wearing away of hard tissue (bone) surrounding dental implants. While peri-implantitis doesn’t usually cause pain, it does cause bleeding, and an individual may notice their implant feels wobbly or loose. Ultimately, peri-implantitis is an infection caused by poor plaque control and lack of regular maintenance.
Arthritis and other degenerative joint diseases can manifest in the soft cartilage disc in the TMJ, leading to inflammation, pain, and wearing away of the cartilage.
Mouth and jaw pain is more than just a nuisance. Untreated, the conditions causing the pain can also cause a lot of damage. Regular dental check-ups are important to prevent and spot these conditions early, and one option a dentist may offer to help with the pain is laser therapy.
How Laser Therapy Helps With Mouth & Jaw Pain
Laser therapy is the application of concentrated red and near-infrared light to be absorbed by the body to aid in the treatment of pain and inflammation. Specifically, red and near-infrared wavelengths of light are absorbed by different tissues in the body and target the mitochondria of the cells in these areas. The light absorbed by the mitochondria affects the heme protein, cytochrome c, which is responsible for the synthesis of a cellular energy molecule, ATP (adenosine triphosphate). The result is increased cellular energy.
Increased cellular energy from laser therapy helps with pain, inflammation, and healing in a few ways. Laser therapy increases the production of certain white blood cells that act as inflammatory mediators to reduce inflammation quickly. The treatment provides pain relief by decreasing levels of the pain-eliciting chemical, bradykinin. Lastly, increased collagen production from laser therapy helps heal wounds faster and reduces the formation of scar tissue.
Laser therapy can be used anywhere on the body, but for the mouth and jaw, laser therapy helps reduce pain following a third molar extraction, relieve pain and restore motion to the TMJ, and reduce inflammation and bleeding from peri-implantitis.
Benefits of Laser Therapy for Mouth & Jaw Pain
During laser therapy, a technician (who may be your dentist or oral surgeon) will move the laser handpiece over the area of your mouth or jaw for a few minutes, not exceeding twenty minutes. The technician may hold the handpiece against the skin, but they won’t need to press into the jaw or cheeks. The laser itself is painless. You may feel a slight warming of the skin if your dentist is using a class IV laser therapy system, but it won’t burn or damage your skin.
There are two major benefits of using laser therapy to manage pain in the mouth and jaw, with the first being that laser therapy is most effective when applied extraorally, or outside of the mouth. If your jaw is tender or difficult to open, you won’t need to strain it further to receive laser therapy treatments. And, as an extra bonus, there won’t be someone else’s hands in your mouth.
The second major benefit of laser therapy for mouth and jaw pain is not needing to rely on oral pain medication. Especially post-oral surgery, taking medication is difficult at best when the mouth is swollen or numb. Additionally, medications like ibuprofen can upset the stomach, and this side effect can be aggravated by taking the medication on an empty stomach. However, severe mouth and jaw pain make chewing difficult, and if you’ve had oral surgery, your diet is generally restricted to prevent damage or infection.
Most people experience no side effects from laser therapy, and the treatments don’t require painstakingly eating a cup of applesauce with a numb or swollen mouth beforehand. Side effects for laser therapy are a mild, temporary dizziness from a peripheral vasodilation effect that may cause a drop in blood pressure and an increase in pain during the first 24 hours; however, most people feel relief quickly following treatment.
Laser therapy is a safe, effective, and painless option to help manage mouth and jaw pain both from common causes like TMJ disorders and post-oral surgery such as a third molar extraction. Laser therapy treatments help reduce pain and accelerate healing by stimulating the body’s natural healing processes.
If you’re looking to try laser therapy, click the link below to find an Aspen Laser provider.
The Difference Between FDA Registered, FDA Approved, and FDA Cleared
We hear a lot about the FDA: in the news, when we’re looking at products in our local pharmacy, at the doctor’s office, and even in the vet’s office. Products from foods to medicines to health monitoring applications tout phrases like “FDA Registered,” “FDA Approved,” and “FDA Cleared.” But what do all of these mean, and does it mean these products are safe or even endorsed by the FDA?
Keep reading to learn the difference between these phrases, what it means to attain them through the FDA, and why FDA regulatory processes are important.
What Does the FDA Do: The Role and Function of the FDA
The FDA, or the Food and Drug Administration, is the government agency in the United States responsible for protecting the public health. The FDA regulates a variety of consumer products, including food, medications, vaccines, medical devices, electronics that emit radiation, cosmetics, veterinary products, and tobacco. For a complete list of what the FDA regulates, see this article.
The responsibility of the FDA is to protect public health by ensuring the safety, efficacy, and security of these products. This means that products are safe to use and benefits outweigh any potential risks, they’re effective for the intended purpose claimed by the manufacturer, and they haven’t been tampered with in order to cause harm (this is why over-the-counter medications have foil seals, for example).
The FDA is responsible for the safety and efficacy of a lot of products, but for the purpose of this article, we’ll focus on how the FDA regulates medical devices.
Additional Regulatory Organizations: CDRH, IEC & ANSI
CDRH – The Center for Devices and Radiological Health
The Center for Devices and Radiological Health (CDRH) is a regulatory bureau within the U.S. Federal Food and Drug Administration (FDA) of the Department of Health and Human Services. They have the responsibility for implementing and enforcing the laws and regulations which apply to radiation- producing electronic products and medical devices that include lasers and light devices.
IEC – The International Electrotechnical Commission
The International Electrotechnical Commission is an international standards organization that prepares and publishes international standards for all electrical, electronic and related technologies – collectively known as “electrotechnology”.
ANSI – The American National Standards Institute
The American National Standards Institute (ANSI) oversees the creation and dissemination of business norms and standards in the United States. ANSI is a private and nonprofit organization that does not develop standards itself, but oversees the creation of voluntary standards for a variety of manufacturing processes, products, systems, services and personnel in nearly every U.S. business sector. It also works to ensure that U.S. standards are consistent with international standards enabling U.S. products to be sold and used abroad.
In addition to its role in promoting standardization, ANSI also works to provide accreditation to organizations that provide certification of products or personnel. ANSI is actively involved in the accreditation programs that oversee those standards, including ISO 9000 (quality) and ISO 13485 (medical devices) management systems.
FDA Classification Levels of Medical Devices: Class I, II, & III
There are three different classifications of medical devices through the FDA, Class I, II, and III. The class a device falls into is determined by the potential risk of using the device, and medical devices include everything from tongue depressors to pacemakers.
Class I medical devices pose minimal risk to the user. They include devices like elastic bandages and tongue depressors. 47% of medical devices are categorized as Class I devices, and most of them (95%) are exempt from regulatory processes. This means most products in this class do not have to undergo any premarket process with the FDA.
Class II medical devices pose a medium risk. This category represents 43% of all devices and includes a wide variety of devices from motorized wheelchairs to some pregnancy test kits to the Apple Watch ECG app. Some Class II devices are exempt from regulatory processes, but most must at least submit a 510(k), or premarket notification.
Class III medical devices pose the most risk to a patient. Only 10% of devices fall into this category. These are devices that are implanted into the body, life sustaining, or otherwise present an unreasonable risk. Class III devices include things like pacemakers, breast implants, and replacement heart valves. These devices must submit an application for Premarket Approval (PMA).
Requirements For Companies
All medical device companies must be registered with the FDA.
Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States are required to register annually with the FDA. This process is known as establishment registration. The required annual registration is a review of all the information for a given facility and its associated device listings. Congress has authorized the FDA to collect an annual establishment registration fee for device establishments. Most establishments that are required to register with FDA are also required to list the devices that are made there and the activities that are performed on those devices. Registration and listing provides FDA with the location of medical device establishments and the devices manufactured at those establishments.
Knowing where devices are made increases the nation’s ability to prepare for and respond to public health emergencies.
Requirements for Medical Devices
All medical devices must be registered with the FDA.
Registering a medical device company and its Class I, II or III medical devices is a requirement to market and sell those products in the United States.
Every manufacturer of medical devices, including businesses that re-pack or re-label such devices, must register annually with the FDA and list their products in the FDA’s Registration & Listing database. Most manufacturers of products in the industries regulated by the FDA have to register with the FDA so the FDA can keep a catalog of all the products under their regulation.
Manufacturers of devices exempt from regulatory processes, or generic devices, still have to register their company with the FDA and list their products with the FDA into the appropriate generic category.
A device that is “only” FDA Registered is not necessarily effective for the specific treatment applications claimed by the manufacturer. Registration simply means the FDA is aware of the manufacturer and their devices. The manufacturer cannot claim the device is “FDA Cleared or Approved”, and they cannot use the FDA logo in marketing or labeling the device.
The FDA is able to monitor the safety of products and devices registered to them through a program called MedWatch. Healthcare professionals, patients, and consumers can use MedWatch to report any serious problems they have with a medical device or product.
The Problems With Buying Devices from Companies Not Registered
Unfortunately, not all medical devices that are sold and bought have been listed with the FDA. Manufacturers in other countries, for example, may not have registered with the FDA and listed their devices, let alone gone through any premarket process. This means that the marketing and sale of these devices as medical devices in the U.S. is illegal.
Using a device that hasn’t been listed, cleared, or approved by the FDA as a medical device is extremely dangerous. The device may be unsafe or ineffective and cause harm to the user or client. Additionally, using a device not listed with the FDA means there is no protection for a healthcare or wellness professional should a client have a harmful experience.
If you’re unsure if a medical device is listed with the FDA, you can search for the manufacturer in the Registration & Listing Database.
FDA Approval: What is Really FDA Approved?
The highest-risk devices (Class III), such as mechanical heart valves and implantable infusion pumps, generally require FDA approval of a premarket approval application before marketing.
To receive FDA approval for these devices, manufacturers must demonstrate with sufficient, valid scientific evidence that there is a reasonable assurance that the devices are safe and effective for their intended uses.
What Else Does The FDA Approve?
New Drugs and Biologics. The FDA approves new drugs and biologics.
Animal Drugs & Food Additives. The FDA approves animal drugs and approves food additives for use in food for animals.
Human Food Additives. The FDA approves food additives in food for people.
Human Cells & Tissues. The FDA uses a risk-based approach for human cells and tissues.
What Doesn’t The FDA Approve?
Companies. The FDA doesn’t approve companies. The FDA does not approve health care facilities, laboratories, or manufacturers; however, the FDA does have authority to inspect regulated facilities to verify that they comply with applicable good manufacturing practice regulations. Owners and operators of domestic or foreign food, drug, and most device facilities must register their facilities with FDA, unless an exemption applies.
Compounded Drugs. The FDA doesn’t approve compounded drugs.
Dietary Supplements. The FDA doesn’t approve dietary supplements.
Cosmetics. The FDA does not approve cosmetics.
Medical Foods. The FDA doesn’t approve medical foods.
Misuse of FDA’s logo may violate federal law
The FDA’s logo is for official government use only. The FDA’s logo should not be used to misrepresent the agency or to suggest that FDA endorses any private organization, product, or service.
FDA Clearances: What is FDA Cleared?
Class 1 devices that present a low risk of harm to the user (for example non-powered breast pumps, elastic bandages, tongue depressors, and exam gloves) are subject to general controls only, and most are exempt from premarket notification requirements 510 (k).
Class II devices are not exempt and require that the FDA “clears” all moderate-risk medical devices (for example, dialysis equipment and many types of catheters) for marketing once it has been demonstrated that the device is substantially equivalent to a legally marketed predicate device that does not require premarket approval.
All medical devices must at least be FDA Registered. However, devices that are not generic or otherwise exempt must go through one of two premarket processes:
- Premarket Notification 510 (k) or
- Premarket Approval
Premarket Notification 510(k) for Class II Devices
If a medical device is not exempt, the manufacturer may submit a 510(k) or Premarket Notification. There are thousands of medical devices available today, so independently and rigorously testing devices that are similar to each other would take ages and ultimately slow progress in improving public health.
A 510(k) allows a manufacturer to submit evidence that their device is similar enough to another device that has been through the Premarket Approval process and obtain clearance to market their product for the same purposes granted by the other product, also called the “predicate.”
Medical devices that go through the Premarket Notification 510(k) process obtain “FDA Clearance”. That is, they’re similar to a predicate in their materials, function, and purpose that they’re most likely not going to pose different or increased risk than the predicate device.
FDA Clearance Versus FDA Approved for Class II Non-Exempt Devices
When a non-exempt medical device has FDA Clearance, the manufacturer can market and sell that device in the U.S. However, they may not market their device as “FDA Approved” because it did not go through the Premarket Approval process. They are permitted to market the device as “FDA Cleared,” but the manufacturer cannot use the FDA logo in their marketing or labeling of the device.
Premarket Approval (PMA) for FDA Approval of New and Class III Devices
New medical devices that are not similar in function, materials, design, or purpose to another device on the market, must submit a Premarket Approval (PMA) application to the FDA in order to be marketed and sold in the U.S. It is important to note that most medical devices DO NOT have to go through the Premarket Approval process.
Only new Class III medical devices need PMA approval. These are devices implanted into the body, life-sustaining devices (i.e. pacemakers), or otherwise pose a significant risk to the patient (i.e. PET scanning devices). Other FDA regulated products that need approval are products like prescription drugs, vaccines, and OTC medications.
The PMA process requires the manufacturer of the device to provide valid evidence from human clinical trials that the device is safe to use and effective for the intended purpose.
IDE: Investigational Device Exemption
To conduct human clinical trials, the manufacturer must obtain an Investigational Device Exemption (IDA). This allows the device to be distributed to the facilities listed in the exemption to conduct clinical trials and collect evidence needed for the PMA application.
FDA Approved means that, through this process, the device has shown that the “benefits of the product outweigh the known risks for the intended use.” Manufacturers whose devices have FDA approval may market their devices as “FDA Approved.”
FDA Status: Aspen Laser Therapy Systems
Aspen Laser, LLC is registered with the FDA, and all of our therapy system models are listed as Class II medical devices.
Class II Physical Medicine Therapeutic Device
Intended uses of Aspen Laser Pinnacle and Summit Systems as therapeutic devices include:
- Relaxation of muscles and relief from muscle spasms
- Temporary relief of minor muscle and joint aches, pain and stiffness
- Temporary relief of minor pain and stiffness associated with arthritis
- To temporarily increase blood circulation
Class II General & Plastic Surgery Device
Intended use of the Aspen Laser Pinnacle and Summit Systems as a general surgery device is to temporarily increase clear nail in patients with onychomycosis.
FDA Product Codes
FDA Regulation Numbers
The Regulation Number for Aspen Laser products as Therapeutic Devices is: 21 CFR 890.5500. This number is listed on each FDA 510K Clearance Letter with the FDA indicating the status of this number on the FDA website:
PART 890 — PHYSICAL MEDICINE DEVICES. Subpart F – Physical Medicine Therapeutic Devices. Sec. 890.5500 Infrared lamp.
The Regulation Number for Aspen Laser Products as General & Plastic Surgery Devices is: 21 CF 878.4810. This number is listed on the on each FDA 510K Clearance Letter with the FDA indicated the status of this number on the FDA website:
PART 878 — GENERAL AND PLASTIC SURGERY DEVICES. Subpart E – Surgical Devices. Sec. 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
Learn more about Aspen Laser Therapy Systems through the link below.
This information first appeared on the TheraLight, LLC website and can be found here.
Non-Pharmacological Treatments for Plantar Fasciitis, Achilles Tendonitis, and Chronic Foot Pain
Our feet are well-worn parts of our bodies that take a lot of abuse, from stubbed toes and twisted ankles to chronic discomfort like tendonitis and arthritis. Foot pain, whether acute or chronic, can stop us in our tracks and interrupt everything from our jobs to our hobbies to spending time with our loved ones.
Looking to stop foot pain before it stops you? Keep reading to see how laser therapy can relieve pain and swelling from overuse, and even treat persistent toenail fungus.
Dangers of Procrastinating Treatment for Foot Pain
When you’re on your feet, there’s always a chance for injury, but chronic foot and ankle pain can cause much more damage if left untreated. Changes to your gait that alleviate tension on your feet can cause additional stress and injury to your legs, knees, hips, and back. The more damage sustained, the more difficult treatment can become.
Common Causes of Chronic Foot Pain
Plantar fasciitis and achilles tendonitis are common causes of pain in the lower leg, heels, and feet. Plantar fasciitis is caused by damage to the plantar fascia, a thick connective ligament between the heel and front of the foot. Consistent pressure from standing for long periods of time or prolonged use of unsupportive footwear during activity are risk factors for plantar fasciitis.
Achilles tendonitis affects the achilles tendon that attaches the calf muscles to the heel. This overuse injury is common in runners and middle-aged weekend warriors.
Left untreated, both of these issues can result in more serious injury. Continuing regular activity without treatment or support for injured tissues creates more risk for a serious tear or rupture. Additionally, letting these conditions persist can result in further damage from chronic inflammation. Surgery to treat extreme damage and relieve severe pain comes with long recovery periods and runs the risk of nerve damage and loss of full function of the foot and ankle.
Laser Therapy for Chronic Foot Pain
Laser therapy is an alternative treatment to traditional pain management. Laser therapy utilizes the energy of red and near-infrared light to boost the body’s natural healing processes instead of masking symptoms like other methods. Treatments with laser therapy last 5-20 minutes and typically require between 6 and 12 treatments to achieve the desired results.
Learn more about how laser therapy works in our article here.
There are several benefits to laser therapy treatments, the first being there are no adverse side effects. While over-the-counter pain relievers can irritate the stomach, and prolonged use can cause kidney or liver damage, laser therapy doesn’t affect any area of the body that was not exposed to the laser.
Laser therapy treatments are also painless, unlike corticosteroid injections that are often used to reduce pain and swelling in joints. And while complete treatment will take multiple regular visits, the relief experienced from laser therapy outlasts that of corticosteroid injections. Additionally, repeated use of cortisone shots can cause more damage to the joint and surrounding soft tissues.
Another benefit of laser therapy is that it can be combined easily with other treatments, such as physical therapy or braces and supports. There is no downtime needed after a laser therapy treatment, so you can go about your day normally afterwards.
Laser Therapy for Toenail Fungus (Onychomycosis)
While not necessarily a cause of pain, toenail fungus, or onychomycosis, can be a persistent issue that is not easily treated and can often return. Laser therapy is an effective treatment for toenail fungus that is approved by the FDA.
How It Works
One of the main complications with treating onychomycosis is thickening of the nail that reduces the effectiveness of topical antifungal treatments. Laser therapy is able to penetrate the nail and nail bed where fungi reside. The thermal energy from a laser treatment kills fungi. Absorbing heat energy from a laser damages the cell envelopes of the fungi, destroying them.
Pulsing laser light is often used when treating onychomycosis to reduce heat on the skin and prevent injury. Because toenail fungus is often persistent, treatment can take between 6 and 18 months.
Alternative to Oral Medications
Just like with pain medications, oral antifungal medications have unwanted and potentially dangerous side effects, such as kidney and liver damage or weakening of the heart’s ability to contract. Another major concern with using oral antifungals is their interactions with other medications or alcohol that can be dangerous.
Laser therapy is an effective and safe treatment for toenail fungus that can be used in combination with topical antifungals or on its own as an alternative to oral antifungal medications.
Laser therapy is a pain-free option for multiple causes of foot pain and irritation. If you’re interested in trying laser therapy, click the link below to find an Aspen Laser provider near you.
Injuries in equine athletes are difficult to treat, and they’re costly and stressful to owners and veterinarians alike. Laser therapy is an option to include in treatment plans for injuries in equine athletes that helps speed up recovery time, reduce pain and inflammation, and reduce the formation of scar tissue.Continue reading
Shared decision making is the process of a clinician and a patient working together to review all the options a patient has for treatment and ensuring the patient feels properly educated before they make a choice.Continue reading
As we approach the new year 2020, there is still time to save on your business taxes for 2019 and position your business for success by adding a Class IV Aspen Laser.Continue reading
You may have seen some new devices popping up in your local gym or wellness centers like cryotherapy chambers and photobiomodulation therapy systems. This blog cover the purpose of both treatments, how they work, and the differences between them.Continue reading