The Food and Drug Administration (FDA) has granted 510(k) clearance to FibroLux laser for adjunctive use in temporary relief of pain associated with fibromyalgia.
FibroLux is a laser based therapy that delivers optimal doses of light energy using a combination of curated wavelengths. The FDA cleared the device based on data from a placebo-controlled, randomized, double-blind, parallel group clinical study (ClinicalTrials.gov Identifier: NCT04322812) that included 90 patients with fibromyalgia. Patients were randomly assigned 1:1 to receive either FibroLux or sham 3 times a week for a total of 9 treatment sessions over a 3-week period.
Findings showed that a greater proportion of patients treated with FibroLux had a clinically meaningful and statistically significant decrease in tender point count (TPC of 20% or greater) compared with those who received placebo (primary endpoint; 86.67% vs 48.89%, respectively; treatment difference, 37.78%; P <.0005).
The mean decrease in TPC from baseline was reported to be 8.00 points in the FibroLux group and 2.71 points in the placebo group. Fibrolux was also associated with a 35.79 point decrease in mean total score on the Fibromyalgia Impact Questionnaire compared with a 20.83 point decrease for placebo. Additionally, mean pain ratings on the 0-100 Visual Analog Scale decreased 42.84 points for the FibroLux arm and 17.98 points for the placebo arm (treatment difference, 24.86 points).
“Laser therapy has been a game-changer in the rehabilitation and pain management space for years,” said Multi Radiance Medical CEO Max Kanarsky. “Now, as the first laser company to achieve a patent and FDA clearance for relief of fibromyalgia pain, this opens the door for how to effectively manage this tough condition.”
- Multi Radiance Medical therapeutic laser receives FDA clearance for the treatment of pain associated with fibromyalgia. News release. Multi Radiance Medical. Accessed October 4, 2022. https://www.businesswire.com/news/home/20221004005022/en/Multi-Radiance-Medical-Therapeutic-Laser-Receives-FDA-Clearance-for-The-Treatment-of-Pain-Associated-with-Fibromyalgia
- Medical devices: product classification. US Food and Drug Administration. Accessed October 4, 2022. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=5460
- Demchak T, Leal-Junior EC. A photoceutical approach to treating fibromyalgia: A scientific monograph. Multi Radiance Medical. Laser Therapy University.