Miami-based medical device manufacturer, Capillus, LLC, announces that the Capillus272™ has received 510(k) clearance from the Food and Drug Administration. With no known side effects and the highest energy output of any home-use low level laser therapy (LLLT) product, the Capillus272 is proven to prevent hair loss and promote hair regrowth in adults who suffer with androgenic alopecia.
Designed for home-use, the Capillus272 is a mobile battery-powered laser product that is worn under a hat for 30 minutes every other day. It applies red laser light to the scalp from its 272 laser diodes.
“We received excellent results from our clinical trial,” says Carlos Piña, Capillus CEO. "We are excited to communicate the proven benefits of our product and to introduce new products and services to serve the needs of physicians and patients.”
More than 55 million men and women suffer with hair loss in the United States. Not everyone is a candidate for a surgical hair transplant procedure, and many who are candidates prefer a more convenient, non-invasive treatment method. LLLT devices provide a safe, non-surgical option designed to reawaken the hair follicles and stimulate natural hair growth.
“It is very gratifying to receive FDA clearance for our Capillus272 Laser,” says Dr. Shelly Friedman, Capillus Medical Director, whose credentials include 26 years of experience and 15,000+ hair transplants performed. “The clearance substantiates what we have known and experienced clinically; that the Capillus272 laser cap is very successful in converting fine, vellus hairs to normal growing hairs. Our premarketing study for FDA clearance revealed a 51% increase in terminal (growing) hair counts over the placebo device. “
With 272 lasers, the FDA-cleared Capillus272 emits more laser energy than any other LLLT product in the market. Its clearance is based on an independently-reviewed clinical trial, and it’s indicated for the treatment of both men and women. It is lightweight and battery-powered unlike other devices in market, which require connection to a power outlet during use. The Capillus is a medical device not sold over-the-counter; instead, it is sold only through licensed physicians with expertise in hair restoration. This assures proper diagnosis for the cause of hair loss to ensure each patient is a good candidate for the therapy.