Capillus Laser Therapy Caps Receive FDA Clearance for Over-the-Counter Use

Capillus LLC, a medical device manufacturer developing hair loss treatment produces, has received U.S. Food and Drug Administration (FDA) clearance for its at-home laser therapy caps for over-the-counter (OTC) treatment of hair loss, as well as its clinical-use Capillus272 OfficePro, making them the only devices of their kind legally available without a prescription in the United States. 
 
Previously, the Capillus82, Capillus202 and Capillus272 OfficePro devices were only available on order of a healthcare professional through Capillus’ physician network and the company directly. This new FDA clearance now allows individuals suffering from androgenetic alopecia to also purchase the device through online retailers and salons. Capillus laser therapy devices are now available on Amazon and select salons and retailers. 
 
Capillus laser therapy caps use safe, low level lasers to energize hair follicles and spur new, natural hair growth. The lightweight Capillus laser caps 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.
 
“This is an exciting development for the millions of people who suffer from hair loss, and we are thrilled to be able to offer them access to a safe and effective over-the-counter laser therapy treatment solution,” said Carlos Pina, CEO of Capillus. 
 
Capillus laser therapy has been clinically proven effective through an independently reviewed trial that showed success in more than 95 percent of active clinical study participants. Participants showed an average of 51 percent more hair within 16 weeks.
 
The announcement of the FDA clearance comes on the heels of Capillus’ receipt of a Class II medical device license by Health Canada late last year, as well as its ISO 13485:2003 certification, 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 cleared for use by the U.S. FDA for both males and females.
 
Capillus is a Miami, Fla.-based medical device manufacturer and marketer of solutions for hair loss. Founded in 2012, the company is a resource for those battling hair loss. Capillus, LLC 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 present-day 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 seven FDA clearances for its seven laser therapy models.
 
Building on its mission to provide customers with the best products in treatment of hair loss, all Capillus products cater to both women & men with thinning hair or at risk for thinning hair, a condition that affects up to 50% of adult women & 80% of adult men.