Palomar Medical Technologies Inc. a maker of laser based cosmetic treatments, has received a 510(k) over-the-counter clearance from the U.S. Food and Drug Administration for a new home-use laser device for the treatment of eye wrinkles.
Burlington-based Palomar (Nasdaq: PMTI) made the announcement this week, claiming the clearance allows the device to be marketed and sold directly to consumers without a prescription. It claims it’s the first company to receive such a clearance, as well. This consumer device was developed by Palomar and Johnson & Johnson Consumer Companies Inc., and is the result of years of research and clinical testing, company officials reported.
The company stated this FDA clearance would allow it to tap into the multi-billion dollar consumer skin care market. Laser-based treatment in the past has been confined to doctors’ offices and has relied on very expensive equipment. This new device will cost only a fraction of what the traditional treatment costs. This isn’t the first such permission for Palomar. In December 2006, it received a 510(k) for a home-use, light-based hair removal device.
In recent months, Palomar has been involved in legal wrangling over its patents with Wayland-based Candela Corp. For the first quarter, which ended on March 31, Palomar reported revenues of $14.7 million. The company also reported net loss of $1.4 million, up from a loss of $1 million the year prior in the same quarter.