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U.S. Department of Health and Human Services

510(k) Premarket Notification

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51 to 60 of 63 Results
ProductCode: GEX Applicant: LUMENIS Decision Date To: 10/26/2016
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opusduo; opusduo e; opusduo ec; opus 20; opus spectrum LUMENIS LTD. K040270 12/16/2004
stellar m22 for intense pulsed light (ipl) and laser system Lumenis Ltd. K193500 01/16/2020
ultrapulse surgical and aesthetic co2 laser system, delivery devices and accessories Lumenis Ltd. K203544 12/24/2020
lightsheer desire light laser system LUMENIS LTD K151947 08/12/2015
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
the ultrapulse system (ultrapulse and ultrapulse duo models,members of the modified lumenis family of ultrapulse surgitouch LUMENIS LTD K151331 06/30/2015
lumenis y&r laser system Lumenis Inc. K211979 06/21/2022
vision one laser system LUMENIS INC. K111213 07/25/2011
the family of ultrapulse co2 surgical and aesthetic lasers, delivery devices and accessories Lumenis Be, Ltd. K220467 05/18/2022
ultrapulse alpha co2 laser system, delivery devices and accessories Lumenis Be Ltd. K233301 12/01/2023
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