FDA laser regulations and chiropractic use

LLLT can be an effective tool for treating patients who have been diagnosed with a variety of injuries that fall within FDA laser regulations and treatments

Low-level laser therapy (LLLT), or photobiomodulation as it is more formally called, began in the 1960s, after Hungarian researcher Endre Mester noticed that laser light was capable of helping mice regrow shaven hair.

Transferring this knowledge and application to humans, Mester began using these types of devices to treat nonhealing skin ulcers. Now today they are utilized for so much more, and FDA laser regulations are paving the way for top suppliers to move the industry forward.

Low-level laser efficacy

According to one systematic review and meta-analysis published in the January 2019 issue of Medicine, LLLT can provide significant relief for patients struggling with heel pain caused by plantar fasciitis. These researchers add that this treatment offers “excellent efficacy” as its effects can last for months.

Recent research also reveals that LLLT can be an effective tool for treating patients who have been diagnosed with a tendon injury. One such study was published in Photomedicine and Laser Surgery in October of 2018 and involved 97 patients with sharp tendon injuries in their hands.

These patients were split into two groups: one which received LLLT (and included 39 patients) and the other that served as a control (58 patients). The LLLT group engaged in 8-10 therapy sessions using red and infrared lasers, after which participants experienced a significant reduction in pain, as well as an increase in passive range of motion. The authors of this study further noted that “all patients in the LLLT group were satisfied.”

Other current studies have noted that LLLT can be beneficial for chronic joint disorders, especially those related to the knees and temporomandibular and zygapophyseal joints, and chronic pain conditions such as rheumatoid arthritis.

However, before low-level lasers can be used to treat these sorts of conditions, they must first obtain approval from the U.S. Food and Drug Administration (FDA).

Understanding the FDA laser approval process

The FDA currently recognizes four classes of lasers (and three subclasses). The higher the class, the more powerful the laser. So, lasers used in the medical field generally fall into classes three and four, with class three including low-level lasers (subclass 3A) and non-surgical lasers (subclass 3B), and class four referring to surgical lasers used to treat conditions such as eye or skin issues.

To gain approval for a new laser device falling into one of these higher classes — or an existing laser device that would be utilized for an additional purpose other than the one that it has been previously been granted acceptance to treat — manufacturers must first seek approval to conduct a clinical investigation using that device. In some cases, approval must also be obtained from an Independent Review Board, or IRB, before this research can begin.

Once approval has been granted and the investigation has been completed, the manufacturer must then submit extremely thorough data explaining how that device performed. Specifically, it must show that the laser is both safe and effective. In other words, if a laser device has obtained FDA laser regulations market clearance, known as 510(k) clearance, this governmental agency has verified its safety and efficacy for treating a particular health condition.

FDA market clearance advances

Research reveals that, between the years 2000 and 2018, a total of 47 LLLT devices have been granted 510(k) premarket approval. Additionally, a large number of these devices gained this approval from 2007 and beyond.

Some of the more recent approvals have been for laser devices designed to help relieve chronic musculoskeletal pain. Others have targeted more specific areas of the body, such as the lower back.

In order to receive FDA laser regulations market clearance, comprehensive studies must be conducted, most of which take a minimum of 2-3 years to complete. In addition to laser-based research studies being extremely lengthy, they are also costly — a basic human study on a certain condition can start at $150-200,000.

Cold Laser News adds that FDA cleared LLLT devices are now being used for a variety of reasons, ranging from the treatment of pain-based health conditions such as tennis an golfer’s elbow, temporomandibular joint disorders (TMJ), and fibromyalgia to helping patients achieve weight loss or a more preferable figure via body contouring. Thus, when using LLLT devices to treat patients in a chiropractic setting, a multitude of options exist.

Having a clearer understanding of low-level laser therapy applications today, as well as being more knowledgeable about how stringent the process is for getting laser devices approved, can help DCs offer this solution to patients with more confidence and ease. It also puts you in a better position to answer any questions they may have about LLLT and how it can help them personally.