Multi Radiance Medical (MRM), a global leader in Super Pulsed Laser therapy technology and photobiomodulation research, announces that the U.S. Food and Drug Administration (FDA) has granted NHN 510(k) clearance for the adjunctive use of the MR5 ACTIV PRO Super Pulsed Laser for the temporary relief of pain associated with lateral epicondylitis.
Lateral epicondylitis (LE) is one of the most common causes of elbow pain, affecting an estimated 10.5 million adults annually worldwide. Although commonly referred to as tennis elbow, the condition more frequently affects working-age adults performing repetitive occupational and daily activities that place stress on the forearm and elbow. The resulting pain can significantly impact grip strength, productivity, recreational activities, and overall quality of life.
A prospective, randomized, triple-blind, placebo-controlled, multi-center clinical study evaluated the effectiveness of the MR5 ACTIV PRO laser for the temporary relief of pain associated with LE. The study met its predefined primary endpoint, with 72% of subjects receiving active treatment achieving clinical success compared to 40% of subjects receiving placebo treatment (p=0.045).
The clinical evidence supporting the FDA clearance of the MR5 ACTIV PRO has been published in BMJ Open, a leading peer-reviewed medical journal. The publication of this randomized, triple-blind, placebo-controlled, multi-center clinical trial provides clinicians and researchers worldwide access to the full study findings and further reinforces the scientific foundation behind the device’s clearance for the temporary relief of pain associated with LE. The publication marks another milestone in MRM’s commitment to developing clinically validated photobiomodulation technologies and advancing the quality of evidence supporting non-pharmacological treatment options.
The new indication adds to MRM’s existing NHN 510(k) clearances for fibromyalgia pain (FibroLux Laser) and neck and shoulder pain (MR4 Laser), reinforcing the company’s commitment to advancing non-invasive treatment options for musculoskeletal pain.
“This FDA clearance represents another important milestone for Multi Radiance Medical and reflects our longstanding commitment to building our business on science, clinical evidence, and regulatory rigor,” said Max Kanarsky, President and Chief Executive Officer of Multi Radiance Medical. “Adding lateral epicondylitis to our growing portfolio of FDA-cleared indications expands the clinical applications of our technology and provides healthcare professionals with an evidence-based, non-invasive, drug-free treatment option for patients suffering from musculoskeletal pain.”
“At Multi Radiance Medical, our objective is not simply to develop technology, but to validate its clinical application through rigorous scientific investigation,” said Douglas Johnson, Chief Science Officer of Multi Radiance Medical. “We conduct these studies and pursue FDA-cleared indications so clinicians can have confidence that the treatments they provide are supported by meaningful clinical evidence, regulatory review, and reproducible outcomes. For patients with lateral epicondylitis, this clearance provides healthcare professionals with a validated, drug-free treatment option supported by a rigorous clinical trial.”
“High-quality clinical research remains essential for advancing evidence-based healthcare,” said Dr. Ernesto Cesar Pinto Leal Junior, principal investigator of the study and Director of the Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT). “Randomized, triple-blind, placebo-controlled studies provide the highest level of clinical evidence and help ensure that healthcare professionals can make treatment decisions with confidence. The successful completion of this trial further strengthens the scientific foundation supporting the use of Super Pulsed Laser therapy for patients with lateral epicondylitis.”
The MR5 ACTIV PRO utilizes MRM’s proprietary combination of 905 nm Super Pulsed Laser, 850 nm infrared, and 660 nm red light technology. The newly cleared treatment protocol was specifically evaluated for the temporary relief of pain associated with LE and demonstrated both safety and effectiveness under labeled conditions.
Learn more about the MR5 ACTIV PRO Super Pulsed Laser here.
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.
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