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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: 10/26/2016
 
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acupulse 30/40 st co2 laser system and acupulse 40wg co2 laser system LUMENIS K100415 04/21/2010
lumenis family of ipl and combination ipl/nd:yag systems LUMENIS K030527 05/20/2003
lumenis versapulse powersuite holmium (ho:yag) and dual wavelength (ho:yag/nd:yag) surgical lasers and delivery devices LUMENIS K011703 08/29/2001
ultrapulse alpha co2 laser system, delivery devices and accessories Lumenis Be Ltd. K233301 12/01/2023
the family of ultrapulse co2 surgical and aesthetic lasers, delivery devices and accessories Lumenis Be, Ltd. K220467 05/18/2022
lumenis y&r laser system Lumenis Inc. K211979 06/21/2022
vision one laser system LUMENIS INC. K111213 07/25/2011
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
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