Palomar Receives FDA Over-The-Counter Clearance for a Home Use Wrinkle Removal Laser Device
Palomar Medical Technologies Inc. (Nasdaq: PMTI), a leading researcher and developer of light-based systems for cosmetic treatments, today announced that it has become the first company to receive a 510(k) over-the-counter (OTC) clearance from the United States Food and Drug Administration (FDA) for a new, patented, home use, laser device for the treatment of periorbital wrinkles. OTC clearance allows the device to be marketed and sold directly to consumers without a prescription.
This consumer device was developed by Palomar and completed together with Johnson and Johnson Consumer Companies, Inc., under a previously announced agreement to develop light-based anti-aging devices. Designed specifically for use in the home and based on years of research and clinical testing, this consumer device represents a major breakthrough in the aesthetic device industry.
- Published: 05 June 2009
- Written by Editor