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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 52 Results
ProductCode: GEX Applicant: LUMENIS Decision Date To: 07/26/2017
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lumenis family of holmium surgical laser lumenis ltd. K170121 05/22/2017
smart laser indirect ophthalmoscope (lio 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 ul lumenis ltd K151331 06/30/2015
lumenis m22 system lumenis ltd. K142860 01/21/2015
et lightsheer 1060, high speed lightshee 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
vision one laser system lumenis inc. K111213 07/25/2011