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

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 and select salons and retailers, in addition to the company’s website,

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 or call toll-free 1-888-272-9599.

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.

Read the full story at

Source: PRWeb
Copyright©2017 Vocus, Inc.
All rights reserved

Related medicine news :

1. Capillus® and National Hair Loss Team to Promote Breast Cancer Awareness
2. Capillus® Laser Caps Are First to Receive FDA Clearance for Male and Female Hair Loss Treatment
3. New Treatment for Excessive Underarm Sweat Now Available at SOMA Skin & Laser in Millburn, NJ
4. Femtosecond Lasers for Cataract Surgery Market
5. Laser Cutting, Drilling, Marking and Engraving Market Worth $3.77 Billion By 2018
6. Laser Eye Center Promotes Vision Education for Diabetes Awareness Month
7. Peter Baker: 25 Years Dedicated to Keeping LIA at the Forefront of Laser Safety & Applications
8. Atlanta LASIK Surgery Center Acquires Latest in Laser Technology
9. North Shore-LIJ Physician Is First to Use Thulium Laser for Prostate Surgeries
10. 4-year-old is First Pediatric Patient in U.S. to Undergo Laser Cataract Removal
11. Last Quarter Witnessing More Treatments at Body Oasis Laser Aesthetics Medical Spa
Post Your Comments:
(Date:6/19/2019)... ... , ... Expanding its commitment to the welfare of children through its new ... for Caterina’s Club during its annual West Coast gala - Notte di Savoia ... donated for the Southern California-based charity from funds raised by the event. The grant ...
(Date:6/19/2019)... ... June 19, 2019 , ... Ovation® Fertility scientists have been invited to present ... Embryology (ESHRE) Annual Meeting in Vienna, June 23-26, 2019. , Ovation’s oral presentation ... both the Basic Science Award for Oral Presentation and the Fertility Society of Australia ...
(Date:6/18/2019)... ... June 18, 2019 , ... Cosmetic Town, an online ... of cosmetic facial rejuvenation in June. The Cosmetic Town website will showcase cosmetic ... performing various methods of cosmetic facial rejuvenation and videos that take viewers behind ...
(Date:6/18/2019)... PLEASANTON, Calif. (PRWEB) , ... June 18, 2019 ... ... (NYSE:TFX) focused on addressing unmet needs in the field of urology, today announced ... designated as a UroLift® Center of Excellence. The designation recognizes that Dr. Aaron ...
(Date:6/16/2019)... Calif. (PRWEB) , ... June 14, 2019 , ... ... / Cyber Security solutions, today announced it has received the coveted “2019 ... award winning DLP that Works Platform along with the latest additions to its ...
Breaking Medicine News(10 mins):
(Date:6/14/2019)... ... June 14, 2019 , ... ... a forecasting and analytics platform that helps Life Sciences Manufacturers accurately project ... for Life Sciences business leaders: accurate, automated forecasting of rebates and discounts ...
(Date:6/13/2019)... ... June 13, 2019 , ... Alliance Cost Containment, LLC (ACC) ... the healthcare space. The $5.8M in savings is in addition to $17.6M saved over ... , With an acquisition in Q4 2019, the client increased their Fortune 500 status ...
(Date:6/13/2019)... Va. (PRWEB) , ... June 13, 2019 , ... The ... new executive director to succeed current executive director Nicholas Croce Jr., MS. The search ... of the Board of Directors, past APNA Presidents, and Council and Chapter leaders. , ...
Breaking Medicine Technology: