US health agency FDA (Food and Drug Administration) approved over-the-counter (OTC) marketing of Palomar’s laser device for treatment of wrinkles around the eyes, i.e. periorbital wrinkles.
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.
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.
Commenting on the achievement, Palomar Chief Executive Officer Joseph P. Caruso said, “This FDA clearance for a laser to treat wrinkles in the home opens up a tremendous opportunity to tap into the multi-billion dollar consumer skin care market with our patented technology. The professional treatment of fine lines and wrinkles using lasers has been well established and proven to be safe and effective for years in the doctors’ office using large and expensive lasers. With this breakthrough, consumers will be able to use similar technology in the privacy of their own home for a fraction of the cost. This latest clearance further validates Palomar’s investment in research and development in the field of light-based anti-aging treatments and adds to the list of distinctions for Palomar as a technology leader in our industry.”
Mr. Caruso continued, “Years ago, we believed that light-based anti-aging applications could be brought to the home. We invested significant resources in research, development, clinical testing, and patent protection to make this a reality and ensure that Palomar would be the leader with this innovative technology. We envision a strong market for this OTC device and an increase in consumer awareness to help drive growth in our professional business.”
Source: Palomar Medical Technologies, USA