SOLON, Ohio, June 10, 2026
Multi Radiance Medical announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the adjunctive use of its MR5 ACTIV PRO Super Pulsed Laser for the temporary relief of pain associated with lateral epicondylitis (tennis elbow). The clearance was supported by results from a prospective, randomized, triple-blind, placebo-controlled, multi-center clinical trial demonstrating significant pain relief benefits in patients with the condition. The approval expands the company’s growing portfolio of FDA-cleared photobiomodulation therapies for musculoskeletal pain management.
Clinical Trial Demonstrates Significant Pain Relief
The FDA clearance was based on a rigorous clinical study evaluating the effectiveness of the MR5 ACTIV PRO laser in patients with lateral epicondylitis. The trial successfully achieved its primary endpoint, with 72% of patients receiving active laser treatment achieving clinical success compared to 40% of patients receiving placebo treatment (p=0.045). The randomized, triple-blind, placebo-controlled, multi-center design provides a high level of clinical evidence supporting the device’s effectiveness for temporary pain relief in patients suffering from this common elbow condition.
Published Clinical Evidence Supports Regulatory Approval
The clinical findings supporting the FDA clearance have been published in BMJ Open, a leading peer-reviewed medical journal. According to Multi Radiance Medical, publication of the study provides clinicians and researchers worldwide with access to detailed trial results while strengthening the scientific foundation behind the device’s regulatory approval. The company stated that the publication reflects its commitment to developing clinically validated photobiomodulation technologies and expanding evidence-based, non-pharmacological treatment options for musculoskeletal disorders.
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Expanding FDA-Cleared Applications for Super Pulsed Laser Technology
The new lateral epicondylitis indication adds to Multi Radiance Medical’s existing FDA-cleared applications, which include treatments for fibromyalgia pain and neck and shoulder pain. The MR5 ACTIV PRO utilizes the company’s proprietary combination of 905 nm Super Pulsed Laser, 850 nm infrared light, and 660 nm red light technology. Company executives highlighted that the latest clearance reinforces the role of non-invasive, drug-free laser therapy as an alternative treatment option for patients experiencing chronic musculoskeletal pain while supporting broader adoption across rehabilitation, sports medicine, and pain management settings.
Source: Multi Radiance Medical press release
