FDA 510(k)

            In the United States and abroad, thousands of devices are developed and placed on the market each year, claiming case studies and medical status. However, many of these claims are backed up with little more than words. In order to protect people from false claims and dangerous devices, the United States requires stringent and rigorous testing and proof in the form of a 510(k) submission to the FDA before being granted clearance to be sold to the public. This testing includes clinical studies and laboratory data provided by the applicant. This data must meet specific requirements and is then reviewed by experts within, and sometimes, outside of the FDA. Only after gaining approval by these experts is an FDA 510(k) cleared status given to a device. The purpose of this submission is to prove the SAFETY and EFFICACY of a Medical Device.

 

            After years of research and development, Sunetics International received it's first FDA 510(k) clearance for it's Laser Hair Brush. Three different models of the Laser Hair Brush were granted FDA 510(k) clearance. The Sunetics Laser Hair Brush was cleared to GROW HAIR and treat hair loss in both men and women on June 27th, 2013.

 

            Sunetics International then provided the FDA with its 510(k) submission for its in-office clinical laser unit. On December 24th, 2013, the Sunetics International Clinical Laser Unit was granted its FDA 510(k) clearance and joined the family of Sunetics devices cleared to be marketed as safe, effective, and proven devices to treat hair loss and grow hair in Men and Women.

 

Sunetics International Clinical Laser Unit has been granted the

following FDA 510(k) number: K132646

Sunetics International hand-held Laser Hair Brush has been granted the

following FDA 510(k) number:  K121920