Multi Radiance Medical Secures Expanded FDA Clearance for Lateral Epicondylitis Following Successful Triple-Blind Clinical Trial
Multi Radiance Medical, a global leader in Super Pulsed Laser technology and photobiomodulation research, has announced that the U.S. Food and Drug Administration has granted 510(k) clearance for the adjunctive use of its MR5 ACTIV PRO Super Pulsed Laser in providing temporary relief of pain associated with lateral epicondylitis.
This regulatory milestone marks an important expansion of the company’s non-invasive pain management portfolio and further strengthens the clinical positioning of its Super Pulsed Laser platform across musculoskeletal conditions.
Expanding FDA-Cleared Use in a Common Musculoskeletal Disorder
Lateral epicondylitis (LE), widely known as “tennis elbow,” is among the most frequently diagnosed causes of elbow pain globally. Despite its athletic nickname, the condition is far more prevalent in non-athletic populations, particularly working-age adults who perform repetitive motions involving the wrist and forearm. It is estimated that more than 10.5 million adults worldwide experience symptoms each year.
The condition develops due to overuse or strain of the extensor tendons that attach to the lateral epicondyle of the humerus. Patients typically report persistent pain on the outer elbow, reduced grip strength, and difficulty performing routine tasks such as lifting objects, typing, or manual labor. Over time, untreated or chronic cases can significantly reduce productivity, limit occupational performance, and negatively impact quality of life.
Against this clinical backdrop, the FDA 510(k) clearance of the MR5 ACTIV PRO expands the range of non-pharmacological treatment options available to healthcare providers seeking alternatives to medication or invasive procedures.
Clinical Evidence Supporting FDA Clearance
The clearance is supported by a robust clinical evidence base derived from a prospective, randomized, triple-blind, placebo-controlled, multi-center clinical trial evaluating the safety and effectiveness of the MR5 ACTIV PRO device for LE-related pain relief.
The study successfully met its predefined primary endpoint. Results demonstrated that 72% of participants receiving active treatment achieved clinical success, compared with 40% in the placebo group, yielding statistically significant outcomes (p=0.045).
The trial design—triple-blind, randomized, and placebo-controlled—represents one of the highest standards in clinical research methodology. Such rigorous study design minimizes bias across participants, investigators, and evaluators, thereby strengthening the validity and reproducibility of the findings.
These results provided critical evidence for regulatory submission and ultimately supported the FDA’s decision to grant 510(k) clearance for this specific indication.
Peer-Reviewed Publication Strengthens Scientific Validation
Further reinforcing the clinical foundation of the technology, the study has been published in BMJ Open, a widely recognized, peer-reviewed scientific journal known for disseminating high-quality clinical research.
Publication in BMJ Open provides clinicians, researchers, and healthcare stakeholders with full access to the study’s methodology, results, and interpretation. It also contributes to the growing body of peer-reviewed literature supporting photobiomodulation as a potential adjunctive therapy in pain management.
The availability of published data enhances transparency and reinforces the credibility of the clinical outcomes associated with the MR5 ACTIV PRO system, while supporting broader acceptance of Super Pulsed Laser therapy in evidence-based medical practice.
Strengthening a Growing Portfolio of FDA-Cleared Indications
The newly cleared indication for lateral epicondylitis adds to Multi Radiance Medical’s expanding portfolio of FDA-cleared applications. The company has previously secured clearance for:
- Fibromyalgia pain relief using the FibroLux Laser
- Neck and shoulder pain relief using the MR4 Laser
With the addition of lateral epicondylitis, Multi Radiance Medical continues to broaden the clinical utility of its technology platform across multiple chronic and acute pain conditions. This diversified indication strategy reflects a broader industry shift toward non-opioid, non-invasive pain management solutions.
Mechanism of Action: Super Pulsed Laser and Photobiomodulation
The MR5 ACTIV PRO system is built on Multi Radiance Medical’s proprietary combination of 905 nm Super Pulsed Laser, 850 nm infrared, and 660 nm red light wavelengths. This multi-wavelength approach is designed to penetrate tissue at different depths and stimulate cellular activity involved in tissue repair and inflammation modulation.
The underlying scientific principle, known as photobiomodulation, involves the interaction of light energy with cellular mitochondria, potentially enhancing ATP production, reducing oxidative stress, and modulating inflammatory pathways.
In the case of lateral epicondylitis, the treatment protocol evaluated in the clinical study specifically targeted pain relief outcomes under controlled, labeled conditions. The results demonstrated both safety and statistically significant efficacy when compared with placebo.
Leadership Perspectives on the Clearance
Commenting on the FDA clearance, Max Kanarsky, President and Chief Executive Officer of Multi Radiance Medical, emphasized the importance of scientific rigor in driving regulatory success.
He noted that the addition of lateral epicondylitis to the company’s portfolio reflects a continued commitment to building clinically validated technologies supported by robust evidence. According to Kanarsky, expanding FDA-cleared indications not only strengthens the company’s market position but also provides clinicians with reliable, non-invasive alternatives for managing musculoskeletal pain.
Douglas Johnson, Chief Science Officer at Multi Radiance Medical, highlighted the company’s focus on translational science and clinical validation. He emphasized that the company’s goal is not only technological innovation but also the generation of reproducible clinical outcomes that meet regulatory standards.
Johnson added that FDA-cleared indications are intended to give clinicians confidence that treatment decisions are backed by rigorous research, regulatory oversight, and statistically meaningful results.
Independent Clinical Perspective
The principal investigator of the study, Dr. Ernesto Cesar Pinto Leal Junior, Director of the Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), underscored the importance of high-quality clinical trial design in advancing evidence-based medicine.
He stated that randomized, triple-blind, placebo-controlled trials remain the gold standard for evaluating therapeutic interventions. According to Dr. Leal Junior, the successful completion of this study strengthens the scientific foundation supporting Super Pulsed Laser therapy as a viable adjunctive treatment for patients with lateral epicondylitis.
Broader Implications for Non-Invasive Pain Management
The FDA clearance of the MR5 ACTIV PRO reflects a broader trend in healthcare toward reducing reliance on pharmacological pain treatments, particularly opioids, in favor of non-invasive alternatives. Photobiomodulation-based therapies are increasingly being explored across rehabilitation medicine, sports medicine, and orthopedic care.
With growing clinical evidence and expanding regulatory approvals, Super Pulsed Laser technologies are positioned to play a larger role in multidisciplinary pain management strategies.
The FDA 510(k) clearance of the MR5 ACTIV PRO for the temporary relief of lateral epicondylitis pain represents a significant advancement for Multi Radiance Medical. Supported by a rigorous randomized clinical trial and publication in BMJ Open, the clearance strengthens the company’s evidence-based approach to developing non-invasive, drug-free pain management solutions.
As the burden of musculoskeletal disorders continues to rise globally, innovations such as Super Pulsed Laser therapy and photobiomodulation may offer clinicians additional tools to improve patient outcomes while reducing dependence on pharmacological interventions.
About Multi Radiance Medical
Multi Radiance Medical is a global medical device manufacturer specializing in proprietary Super Pulsed Laser technology and therapy solutions. The company’s FDA-cleared devices are used worldwide by healthcare professionals seeking non-invasive treatment options for pain management, rehabilitation, sports medicine, and musculoskeletal conditions. Through ongoing research, innovation, and clinical collaboration, MRM continues to advance the science and application of therapeutic laser technology.
