Capillus Laser Therapy Receives Medical Device License Approval in Canada

Capillus LLC, a developer and manufacturer of hair loss treatment products, has been issued a Class II Medical Device License by Health Canada for its laser hair therapy at-home laser caps. Capillus is the first low-level laser therapy (LLLT) cap manufacturer to be cleared by Health Canada, according to the company. 
 
Capillus laser therapy caps use safe, low-level lasers to energize hair follicles and spur new, natural hair growth. The lightweight Capillus laser caps, which are also cleared by the U.S. Food and Drug Administration (FDA), are discreet and allow patients to enjoy the proven benefits of laser hair restoration on their own schedule without having to visit a physician’s office. All are designed to be worn on the inside of an ordinary baseball cap or head covering, eliminating the “shame factor” typically associated with hair loss treatment. The routine is as simple as wearing the cap for 30 minutes, three times a week.
 
“The receipt of our Medical Device License from Health Canada, one of the leading and most advanced healthcare markets in the world, is another testament to the strong quality-support system we have in place to protect the best interest of our customer,” said Carlos Pina, CEO of Capillus. “We look forward to providing health care providers and the patient community throughout Canada access to a safe and effective laser therapy treatment solution for hair loss, which has been inaccessible until now.”
 
The Class II Medical Device License demonstrates evidence of the device’s safety and effectiveness. It also legally permits the sale of Capillus’ complete line of laser hair therapy caps: Capillus272 Pro, Capillus202, and Capillus82, which has been highly anticipated in the Canadian market for several months. Capillus will begin distribution in Canada immediately.
 
The announcement comes on the heels of Capillus’ ISO 13485:2003 certification earlier this fall, which was received through the Medical Device Single Audit Program (MDSAP) pilot and ensures Capillus meets current Good Manufacturing Practices set by the FDA. Capillus is the only company specializing in laser therapy for hair regrowth to receive the certification.
 
Capillus became the first low level laser therapy manufacturer to receive FDA clearance for male and female hair loss treatment in May 2016.
 
Capillus is a Miami, Fla.-based manufacturer and marketer of hair loss treatment solutions. Founded in 2012, the company is a resource for those battling hair loss, a condition that affects up to 50 percent of adult women and 80 percent of adult men. Capillus serves the physician and the consumer market with medical laser devices and cosmetic products. The company also connects patients to hair transplant surgeons and dermatologists for both surgical and non-invasive treatment options. 
 
Capillus was founded in October 2012 and received its first FDA 510(k) clearance in January of 2015.  Capillus has been manufacturing its medical laser devices since January 2015. The company moved to its current 20,000-square-foot location in the area of Doral, Fla., to expand its manufacturing facilities in June of 2015 and has been experiencing steady growth with a total of five FDA 510(k) clearances for its four laser therapy models.