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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 63 Results
ProductCode: GEX Applicant: LUMENIS Decision Date To: 05/25/2015
 
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vision one laser system LUMENIS INC. K111213 07/25/2011
versapulse model p20 laser system LUMENIS, INC. K100228 02/24/2010
ultrapulse surgical and aesthetic co2 laser system, delivery devices and accessories Lumenis Ltd. K203544 12/24/2020
ultrapulse alpha co2 laser system, delivery devices and accessories Lumenis Be Ltd. K233301 12/01/2023
the ultrapulse system (ultrapulse and ultrapulse duo models,members of the modified lumenis family of ultrapulse surgitouch LUMENIS LTD K151331 06/30/2015
the family of ultrapulse co2 surgical and aesthetic lasers, delivery devices and accessories Lumenis Be, Ltd. K220467 05/18/2022
stellar m22 for intense pulsed light (ipl) and laser system Lumenis Ltd. K193500 01/16/2020
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
selecta family of ophithalmic laser systems LUMENIS, INC. K081704 09/11/2008
selecta 7000 frequency doubled, q-switched nd:yag ophthalmic laser LUMENIS, INC. K004006 03/26/2001
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