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U.S. Department of Health and Human Services

510(k) Premarket Notification
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11 to 20 of 63 Results
ProductCode: GEX Applicant: LUMENIS Decision Date To: 10/04/2015
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m22 and resurfx systems LUMENIS, LTD. K170060 08/09/2017
lumenis family of holmium surgical lasers and delivery devices and accessories Lumenis Ltd. K170121 05/22/2017
smart laser indirect ophthalmoscope (lio); laser delivery device for lumenis novus spectra laser system, lumenis vision one laser system, and lumenis smart532™ laser system LUMENIS LTD K162837 02/28/2017
lumenis smart532 laser system LUMENIS, INC. K151109 10/30/2015
lightsheer desire light laser system LUMENIS LTD K151947 08/12/2015
the ultrapulse system (ultrapulse and ultrapulse duo models,members of the modified lumenis family of ultrapulse surgitouch LUMENIS LTD K151331 06/30/2015
lumenis m22 system Lumenis Ltd. K142860 01/21/2015
et lightsheer 1060, high speed lightsheer 1060 LUMENIS LTD. K133319 03/20/2014
lumenis pulse 120h LUMENIS LTD. K140388 03/14/2014
fiberlase endure co2 fiber LUMENIS LTD. K130164 03/24/2013
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