Lumenis Ltd announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to the first application-guided pulsed CO2 laser, the UltraPulse SurgiTouch.

The UltraPulse SurgiTouch is the first pulsed CO2 laser to offer an intuitive, versatile interface featuring pre-set parameters by specialty, application and suggested delivery device. Clinical indications include numerous surgical applications in otorhinolaryngology, gynecology, aesthetic, neurosurgery, podiatry, orthopedic, general surgery, thoracic surgery, arthroscopy, dental and oral surgery and genitourinary.

According to Robert Grant, Executive Vice President of Lumenis, the laser system will be the first to result from the combined R&D advances of the two companies -- Coherent Medical Group and ESC Sharplan -- which last year merged to form Lumenis. "The innovative blending of the pulsed radio-frequency excited CO2 laser technology of the UltraPulse from Coherent and the advanced scanning capability of the ESC Sharplan SurgiTouch takes CO2 laser surgery to new heights," Grant said. "The UltraPulse SurgiTouch is the first 'smart' laser. It stands out for its ease-of-use, superior precision, and unparalleled patient outcomes."

Lumenis is the leader in the surgical CO2 laser market. The Company has the largest installed base of surgical CO2 laser systems, with over 50% market share of medical CO2 lasers worldwide.

"Based upon my initial ENT clinical study, primarily focusing on pharyngo-larynx surgery, it is clear this new laser continues the innovation legacy of Coherent and ESC Sharplan," said Professor Marc Remacle, Louvain University Hospital, Belgium. "The UltraPulse SurgiTouch could become the gold standard among ENT CO2 lasers."

Since its introduction in the 1960's, the CO2 laser has been the surgeons' preferred source of energy for vaporizing, excising, incising and ablating soft tissues. The CO2 laser's absorption characteristics and reduced thermal necrosis provide the precise hemostasis level required for a multitude of surgical procedures.

"Now, the first application-guided pulsed CO2 laser enables surgeons to focus on the surgery itself, without concern for set-up details," added Grant. "The UltraPulse SurgiTouch truly brings laser surgery to the surgeon's fingertips. This latest Lumenis innovation strongly reinforces our company's ongoing leadership in the surgical laser industry."