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Lumenis Ltd. (LUME) Receives FDA Clearance for ResurFX™, New Fractional Non-Ablative Module for M22™ Aesthetic Platform



9/16/2013 7:38:50 AM

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Lumenis Receives FDA Clearance for ResurFX(TM), New Fractional Non-Ablative Module for M22(TM) Aesthetic Platform

YOKNEAM, ISRAEL--(Marketwired - September 16, 2013) - Lumenis Ltd., the world's largest medical laser company for ophthalmic, surgical and aesthetic applications, today announced that the Company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for ResurFX™, a new fractional non-ablative laser module. ResurFX is the latest application module for Lumenis' M22™ platform, expanding its capabilities to perform true fractional non-ablative skin resurfacing, one of the fastest growing minimally invasive procedures in recent years.

ResurFX uses a 1565 nm fiber laser and a unique CoolScan™ scanner, which, unlike other non-ablative fractional technologies, enables a homogeneous and uniform pattern of coagulation columns, and requires only one pass. This feature saves practitioners' time and helps protect the patient's skin. The scanner also allows the user to choose from more than 600 combinations of shape, size and density for optimal treatment and results. CoolScan uses a proprietary algorithm that places each fractional spot in a controlled, non-sequential manner allowing the tissue to relax between pulses and providing protection from overheating.

"As a dermatologist, I'm always looking for laser treatments that strike the right balance between efficacy and patient comfort," said Dr. Arielle N. B. Kauvar, MD, Director, New York Laser & Skin Care. "With ResurFX, we have a solution that improves facial and body skin tone and texture with minimal discomfort and downtime."

Lumenis' M22 is the only multi-application platform that combines three gold-standard technologies covering over 30 indications in one system: Intense Pulsed Light (IPL) with Optimal Pulse Technology™, Multi-spot Nd:YAG and now the ResurFX for a complete aesthetic workstation.

"The ResurFX module with the CoolScan scanner allows me to treat patients faster and with greater efficacy, without having to compromise on patient comfort and safety," said Mitchel P. Goldman, MD, Volunteer Clinical Professor of Dermatology, University of California, San Diego. "M22 with ResurFX is a cost effective solution for me to treat the broadest range of my patients' skin conditions."

"We now are able to offer dermatologists three gold-standard technologies in a single platform," said Mr. Roy Ramati, Vice President & General Manager of the Aesthetic Strategic Business Unit at Lumenis. "With 11 new products in recent years and several more on the near horizon, Lumenis is committed to advancing our legacy of innovation that dates back to 1966 when the Company introduced the first medical laser for commercial use."

ResurFX will be one of several Lumenis products featured at the 5-Continent Congress (5CC), which takes place from September 18 - 21 in Cannes.

Key Presentations Highlighting Lumenis Technologies at 5CC

                                                                            
Fractional CO2 in Burns                         Dr. Matteo Tretti Clementoni
Sept. 19, 15:15 - 16:15, Salle de Rédaction II                              
                                                                            
Dual Impact for Treating Striae Distensae       Dr. Matteo Tretti Clementoni
(Alba)                                                                      
Sept. 20, 10:00 - 11:00, Auditorium J                                       
                                                                            
Combining Ablative and Non-Ablative Light       Dr. Miroslava Kadurina      
Sources or Scar Revision                                                    
Sept. 20, 11:45 - 12:45, Salle de Presse                                    
                                                                            
Comparative Comfort of Hair Removal Lasers      Dr. Doris Day               
Sept. 20, 16:15 - 17:15, Salle de Presse                                    
                                                                            
Pearls and Pitfalls in Laser-assisted           Prof. Alina Fratila         
Blepharoplasty                                                              
Sept. 21, 16:15 - 17:15, Salle de Rédaction II                              
                                                                            

ResurFX will also be featured at the American Society for Dermatologic Surgery Annual Meeting (October 3-6, Chicago) in a scientific presentation on Thursday, October 3 at 7:00 pm.

About Lumenis
Lumenis is a global leader in the field of minimally-invasive clinical solutions for the Surgical, Ophthalmology and Aesthetic markets, and is a world-renowned expert in developing and commercializing innovative energy-based technologies, including Laser, Intense Pulsed Light (IPL) and Radio-Frequency (RF). For nearly 50 years, Lumenis' ground-breaking products have redefined medical treatments and have set numerous technological and clinical gold-standards. Our drive for innovation stems from an uncompromising commitment to improving the health and well-being of our patients; addressing new and growing needs of aging populations and in offering medical professionals cutting-edge solutions that fit seamlessly into the health-economics environment of the 21st century. The world over, we bring Energy to Healthcare.
For more information visit: www.lumenis.com.

CoolScan™, Optimal Pulse Technology™, ResurFX™, Lumenis® and the Lumenis logo are trademarks or registered trademarks of Lumenis, Ltd.


Contact information:
Jeff Jacomowitz for Lumenis
(212) 867 1762
jrjacomowitz@lazarpartners.com

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