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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.

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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.

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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.

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