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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 13 Results
ProductCode: GEX Applicant: Lumenis Ltd. Decision Date To: 05/01/2024
 
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ultrapulse surgical and aesthetic co2 laser system, delivery devices and accessories Lumenis Ltd. K203544 12/24/2020
acupulse w co2 laser systems, delivery devices and accessories Lumenis Ltd. K202428 10/22/2020
acupulse w co2 laser systems, delivery devices and accessories Lumenis Ltd. K201663 07/16/2020
stellar m22 for intense pulsed light (ipl) and laser system Lumenis Ltd. K193500 01/16/2020
acupulse (previously called acupulse 30/40 st); acupulse 40w g; acupulse duo Lumenis Ltd. K180597 04/03/2018
lightsheer desire; lightsheer desire light; lightsheer duet; lightsheer infinity Lumenis Ltd. K170179 09/18/2017
lumenis family of holmium surgical lasers and delivery devices and accessories Lumenis Ltd. K170121 05/22/2017
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
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