Solta Medical Announces FDA 510(k) Clearance of New Fraxel re:store(R) Dual Laser System
October 14 2009 - 4:30PM
PR Newswire (US)
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
ABOUT SOLTA MEDICAL, INC. 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 http://www.solta.com/. 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. DATASOURCE: Solta
Medical, Inc. CONTACT: Michael Hromadik of Solta Medical, Inc.,
+1-510-780-4694, ; or Media Relations, Chris Lalli of Cohn &
Wolfe, +1-415-365-8540, , for Solta Medical, Inc. Web Site:
http://www.solta.com/
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