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Hospital Healthcare Europe

New laser therapy cleared by EMEA


10 April, 2008  

Reliant Technologies Inc, the pioneer of fractional resurfacing and market leader of aesthetic laser skin treatments, today announced the European launch of the Fraxel re:pair laser system with this month’s CE Mark (Conformite Europeenne) approval.

The European debut of the Fraxel re:pair system will take place at the Anti-Aging Medicine World Congress on 10-12 April in Paris, France.

The Fraxel re:pair system is now available to dermatologists and plastic surgeons in the European Union, as well as Africa, the Middle East, Australia and Hong Kong. In December 2007, the Fraxel re:pair system received the industry’s only FDA 510(K) clearance for a fractional ablative laser system for treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia.

The industry’s only minimally invasive, ablative fractional laser system, the Fraxel re:pair laser delivers a full spectrum of aesthetic treatment from Fractional MicroDermAblation (FMDA) treatment to Fractional Deep Dermal Ablation (FDDA) treatment.

It is the only ablative resurfacing device capable of being operated by a single clinician because of its built-in smoke evacuation system, and capable of treating at depths from 300 micrometers to 1.6 mm into the dermis, all in a single hand piece.

“Ablative fractional skin resurfacing with the Fraxel re:pair laser is the biggest breakthrough for wrinkle removal in the last 10 years,” said Christopher Zachary, FRCP, chair of the Department of Dermatology, University of California at Irvine.

“Results approach those we can achieve with a facelift, with very few complications and limited downtime. The Fraxel re:pair system produces significant tissue tightening, wrinkle reduction and textural improvement, both on and off the face.”

The Fraxel re:pair laser system, the result of two years of clinical research, represents a new category in skin rejuvenation: Ablative Fractional Resurfacing (AFRTM) treatment. The Fraxel re:pair laser delivers FMDA treatments for superficial photodamage, including pigmentation, fine lines, texture and vascular dyschromia.

It also has the flexibility to deliver FDDA treatment for more severe rhytides and furrows by stimulating new collagen and elastin production deep into the dermis.

Treatment is delivered with the safety and proven efficacy of a Fraxel brand treatment.

Highlights of the more than two-year multi-site clinical study will be presented at the Anti-Aging Medicine World Congress.

Reliant Technologies Inc