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Solta Medical Announces FDA 510(k) Clearance of New Fraxel re:store(R) Dual Laser System

HAYWARD, Calif., Oct. 14 /PRNewswire-FirstCall/ -- Solta Medical, Inc. (Nasdaq: SLTM), the pioneer in fractional resurfacing and market leader of aesthetic skin treatments, today announced it has received FDA 510(k) clearance for the new Fraxel re:store Dual laser system. The Fraxel re:store Dual system takes the industry leading fractional laser technology to the next level by adding a novel 1927 nm wavelength, the first ever application of a Thulium laser in the aesthetics market. The new Fraxel re:store Dual system is optimized for both on face and large body areas to address clearance of pigmentation and other superficial skin conditions all in a single treatment.

Prior to the non-ablative Fraxel re:store Dual system, laser skin resurfacing procedures were largely limited to the face. The expanded versatility of the Fraxel re:store Dual system, with the addition of the new 1927 nm wavelength, increases the areas of the body that physicians can treat and further demonstrates Solta's dedication to producing the safest and most effective aesthetic energy devices in the industry.

"Solta Medical is committed to developing innovative, safe, and effective anti-aging solutions that deliver superior results for patients with the most advanced aesthetic treatments available today," said Stephen J. Fanning, Chairman of the Board, President and CEO of Solta Medical, Inc. "Treatments with new Fraxel re:store Dual system result in smoother, fresher looking skin with less downtime as compared to ablative treatment options. In addition, physicians are now able to treat multiple body areas in one treatment session."

The new Fraxel re:store Dual system provides significant enhancements that enable physicians to better address pigmentation and other dyschromia on the entire body. Fraxel re:store Dual system features and benefits include:

  • Dual fiber laser technology in one system providing the most effective non-ablative skin resurfacing treatment
  • Accelerated clearance of unwanted pigmentation via ground-breaking technology
  • Ease of operation and improved patient comfort with focal cooling built directly into the hand piece
  • Treatment of larger and multiple body areas in a single session with the addition of the 1927 nm wavelength
  • Increased procedure speed by 25% with newly improved scanner design


Solta Medical is a global leader in the medical aesthetics market providing innovative, safe, and effective anti-aging solutions for patients that enhance and expand the practice of medical aesthetics for physicians. The company offers products to address aging skin under the industry's two premier brands: Thermage® and Fraxel®. Thermage is an innovative, non- invasive radiofrequency procedure for tightening and contouring skin. As the leader in fractional laser technology, Fraxel delivers minimally invasive clinical solutions to resurface aging and sun damaged skin. Since 2002, approximately one million Thermage and Fraxel procedures have been performed in nearly 80 countries. Thermage and Fraxel are the perfect complement for any aesthetic practice. For more information about Solta Medical, call 1-877-782-2286 or log on to

The Fraxel re:store 1550 nm laser is FDA cleared for skin resurfacing and for the treatment of pigmented lesions, acne scars, melasma, mild to moderate periorbital rhytids, surgical scars and actinic keratosis. The Fraxel re:store 1927 nm laser is FDA cleared for dermatological procedures requiring the coagulation of soft tissue.

© 2009 Solta Medical, Inc. All rights reserved. Thermage, Fraxel, Fraxel re:store and Solta Medical are trademarks or registered trademarks of Solta Medical, Inc. or its subsidiaries.

SOURCE Solta Medical, Inc.

SOURCE Solta Medical, Inc.
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