First FDA Clearance for Combination Fractional Resurfacing

Tuesday, January 18, 2011

Palomar Offers New Skin Rejuvenation Platform and
Announces the First FDA Clearance for Combination Fractional Resurfacing

Burlington, MA., [January 18, 2011] - Palomar Medical Technologies, Inc., a leading researcher and developer of lasers and pulsed-light systems for aesthetic treatments, is pleased to announce that the Artisan™ Aesthetic System is now being shipped. The Artisan provides a combined fractional ablative and fractional non-ablative laser skin resurfacing treatment - the first approach of this kind to receive clearance by the United States Food and Drug Administration.
The Artisan Aesthetic System includes a 1540 nm or 1440 nm non-ablative fractional laser and a 2940 nm ablative fractional laser for skin resurfacing and a MaxG™ optimized light handpiece for the treatment of pigmented and vascular lesions.  Palomar's new FDA clearance covers the combination use of both the non-ablative and ablative fractional lasers during the same treatment session.  Palomar believes that this specific collection of skin resurfacing and photofacial technologies allows practitioners to tailor a complete skin rejuvenation regimen for each individual client.


"Artisan combines the best of our non-ablative and ablative fractional laser technologies with our optimized light technology. This combination of technologies can be used to improve skin tone and texture, along with specific laser treatments for wrinkles, scars, and stretch marks. Practitioners now have the multiple technologies they need for an overall best-in-class treatment depending on each individual client's age, skin condition, and downtime preference." said Joseph P. Caruso, Palomar's President and Chief Executive Officer.


Palomar's unique combination ablative and non-ablative fractional treatment provides a direct benefit to clients. Arielle Kauvar, MD, director of New York Laser and Skin Care, said, "What is special about Artisan is that I customize just the right amount of ablative or non-ablative fractional treatment to fit each patient's needs for facial rejuvenation, as each patient has different preferences for speed of treatment, downtime, and the number of treatments they're willing to undergo. With Artisan, I can also treat the many patients who have scars and stretch marks." In 2009, Palomar received the first FDA clearance for the treatment of stretch marks using a fractional laser.


"Our goal is to ensure our customers can access our leading technology with packaging and pricing programs that best fit their financial needs.  No other aesthetic system provides so many superior technologies for facial rejuvenation in one package, cost-effectively," said Mr. Caruso.  "Palomar continues to offer product configurations that fit into today's economy. Aesthetic providers now have the ability to match our technology to fit not only their clinical needs, but their financial constraints as well," continued Paul S. Weiner, Senior Vice-President, Chief Financial Officer, and Treasurer.


To learn more about the Artisan Aesthetic System, and Palomar's unique FDA clearance for a combination fractional resurfacing treatments, please visit .


About Palomar Medical Technologies, Inc.: Palomar is a leading researcher and developer of light-based systems for aesthetic treatments.
Palomar pioneered the optical hair removal field, when, in 1997, it introduced the first high-powered laser hair removal system. Since then, many of the major advances in light-based hair removal have been based on Palomar technology.
As a pioneer of fractional technology, Palomar is an owner of fundamental intellectual property in this area. In December 2009, Palomar received the first FDA clearance for the treatment of stretch marks using a fractional non-ablative laser. In September 2010, Palomar received the first FDA clearance for a fractional ablative and fractional non-ablative combination treatment.
In December 2006, Palomar became 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, light-based hair removal device. In June 2009, Palomar became the first company to receive a 510(k) OTC clearance from the FDA for a new, patented, home-use, laser device for the treatment of periorbital wrinkles. OTC clearance allows the product to be marketed and sold directly to consumers without a prescription.


There are now millions of light-based aesthetic procedures performed around the world every year in physician offices, clinics, spas and salons.  Palomar is testing many new and exciting applications to further advance the aesthetic market and other surgical applications.


For more information on Palomar and its products, visit Palomar's website at www.palomarmedical.com.

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