FDA 510(k) Applications Submitted by LUMENIS LTD

FDA 510(k) Number Submission Date Device Name Applicant
K151331 05/19/2015 The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch LUMENIS LTD
K151947 07/15/2015 LightSheer Desire Light Laser System LUMENIS LTD
K162837 10/11/2016 Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532Ö Laser System LUMENIS LTD


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