Capillus® Laser Therapy Caps Receive FDA Clearance For Over-The-Counter Use

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First Laser Therapy Cap to be cleared for OTC use and now available on Amazon.com.

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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.

Capillus®, LLC, a medical device manufacturer focused on providing customers with the best products in treatment for hair loss, announced today that the U.S. Food and Drug Administration (FDA) has cleared its at-home laser therapy caps for over-the-counter (OTC) treatment of hair loss, as well as its clinical-use standing laser unit, making it the only such device legally available without a prescription in the United States.

Previously, the Capillus82™ and Capillus202™ home-use laser therapy caps and the Capillus272 OfficePro™ standing unit for clinical use were only available on order of a healthcare professional through Capillus’ physician network. This new FDA 510(k) clearance now allows individuals suffering from hereditary hair loss to also purchase the devices through online retailers and salons. Capillus laser therapy devices are now available on Amazon.com and select salons and retailers, in addition to the company’s website, http://www.capillus.com.

About Capillus Home-Use Laser Therapy Caps
Capillus laser devices use safe, low level lasers to energize hair follicles and spur new, natural hair growth through photobiomodulation. The lightweight Capillus laser caps are discreet and allow those with hereditary hair loss 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 the provided Capillus hat or an ordinary baseball cap, eliminating the embarrassment that can be associated with other hair restoration devices. The routine is as simple as wearing the cap for 30 minutes, every other day.

About Capillus Clinical-Use Laser Therapy Unit
The Capillus272 OfficePro offers users the flexibility to undergo laser therapy at physicians’ practices and salons before purchasing a device of their own. Salons can now offer this treatment to their regular clients with thinning hair as an additional service.

“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, chief executive officer, Capillus, LLC.

Capillus laser therapy has been clinically proven effective through an independently reviewed trial that showed success in over 95 percent of active clinical study participants. Participants showed an average of 51 percent more hair within 17 weeks.

The announcement of the FDA 510(k) Clearance (K163170) 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.

If you are a salon or other retail owner interested in offering Capillus laser therapy devices for hair regrowth to your customers, please call 786-888-6249.

To learn more about laser hair restoration with Capillus, please visit https://www.capillus.com/ or call toll-free 1-888-272-9599.

ABOUT CAPILLUS, LLC
Capillus, LLC is a Miami-based medical device manufacturer & 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 (Capillus82, Capillus202, Capillus272 Pro, & Capillus272 OfficePro) and cosmetic products which include a line of clinical hair care products and keratin hair fibers. The company also connects patients to hair transplant surgeons & dermatologists for both surgical & 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 25,000 square foot location in the area of Doral to expand its manufacturing facilities in June of 2015 and has been experiencing steady growth with a total of 7 FDA 510(k) clearances for its seven laser therapy models, including both genders and OTC.

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 and 80% of adult men.

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Frances Pina-Brea
Capillus
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