Lumenis wins FDA 510(k) approval for AcuPulse automated CO2 laser surgery tool

JANUARY 5, 2009--Lumenis Inc. (Yokneam, Israel and Santa Clara, CA), said today that the US Food and Drug Administration (FDA) has approved its new AcuPulse CO2 Laser for ENT (ears, nose and throat), gynecology, neurosurgery, general surgery, and aesthetic medicine--and the company is simultaneously introducing the product to market.

JANUARY 5, 2009--Lumenis Inc. (Yokneam, Israel and Santa Clara, CA), said today that the US Food and Drug Administration (FDA) has approved its new AcuPulse CO2 Laser for ENT (ears, nose and throat), gynecology, neurosurgery, general surgery, and aesthetic medicine--and the company is simultaneously introducing the product to market.

AcuPulse was designed for automated CO2 laser surgery, it benefits from Lumenis's years of experience with its Sharplan Compact product line, the company says. Considering human factors and efficacy as major concept goals, the "SurgiTouch" automation and robotics features are controlled from a large area video screen that assures simple communication with the user.

With the AcuPulse CO2 laser and SurgiTouch automation system, surgeons can now focus on the surgery--not the laser set-up, the company boasts. "Physicians can achieve reproducible outcomes at the push of a button by simply selecting the laser application on an intuitive user interface," said Mr. Dov Ofer, Lumenis' Chief Executive Officer.

Video animations display the assembly instructions for various laser accessories, making it simple for operating room staff to become quickly familiar with the system. "In a busy environment like ours where many nurses rotate between operating rooms, this is an invaluable feature that assure quick readiness of the AcuPulse and improves operating room turn over. In addition, I like its wide range of automated procedures which makes it easy to train my residents," said Prof. Marc Remacle, Otolaryngologist - University Hospital of Mont-Godinne, Yvoir, Belgium.

"Ergonomic and human factors were heavily considered at the outset of the project as these provide a tremendous benefit to surgeons and their patients," said Mr. Lloyd Diamond, Senior Vice President and General Manager of Lumenis' Surgical Business Unit. "Personalized log-in with password stores individual settings and preferences," said Diamond. A 'My Settings' feature allows storage of treatment pearls and other data."

Lumenis, Israel's largest medical device company with more than 800 employees worldwide, is a global developer, manufacturer and seller of laser, light-based and radiofrequency devices for surgical, aesthetic, and ophthalmic applications.

More information:
SurgiTouch, as implemented in Lumenis's Ultrapulse

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