"Professional Laser Hair Therapy... .... in the Palm of Your Hand" The Sunetics Laser Hair Brush was designed in the United States by Dr. Charles Maricle and is manufactured under strict quality assurance guidelines. The Sunetics Laser Hair Brush has patents pending in the US and around the world.Sunetics International started in the hair enhancement industry with its Model "E" Clinical Laser. This laser was incredibly successful and was quickly sold to clinics around the U.S. and abroad. The Sunetics Laser Hair Brush was developed to meet the need of clients who could not attend or could not afford treatments at local clinics. This unit complies with FDA / CDRH regulation 21 CFR 1040.10 and 21 CFR 1040.11 as of the date of manufacture.Center for Devices and Radiological Health/Federal drug Administration Variance Number: C.D.R.H./F.D.A 96R0556-03Sunetics International only sells the above Clinical Laser System to Physicians or Medically Supervised Facilities.