FDA Clears Lumenis Surgical Laser
YOKNEAM, Israel, Nov. 8 -- Lumenis Ltd. announced that the US Food and Drug Administration has granted 510(k) clearance for its application-guided pulsed CO2 laser, the UltraPulse SurgiTouch.
Lumenis said the 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 uses include 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 Coherent Medical Group and ESC Sharplan, which merged last year to form Lumenis.
For more information, visit: www.lumenis.com
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