Capillus, LLC, a medical device manufacturer focused on providing customers with the best products in treatment for hair loss, announced today that it 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, the Canadian federal regulator responsible for licensing medical devices.
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 United States Food & Drug Administration, 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, chief executive officer, Capillus, LLC. “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’s 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’s ISO 13485:2003 certification last month, 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.
