FDA 510(k) Applications Submitted by DORNIER MEDTECH AMERICA, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K011322 05/01/2001 DORNIER SAPPHIREERBIUM HANDPIECE, DORNIER SAPPHIRESPOT HANDPIECE DORNIER MEDTECH AMERICA, INC.
K002929 09/20/2000 DORNIER COMPACT ALPHA LITHOTRIPTER DORNIER MEDTECH AMERICA, INC.
K983963 11/06/1998 DORNIER MEDILA H DORNIER MEDTECH AMERICA, INC.
K964760 11/27/1996 DORNIER MEDILAS FIBER TOME LASER DORNIER MEDTECH AMERICA, INC.
K110364 02/07/2011 DORNIER MEDILAS D LITEBEAM+ 1470 DORNIER MEDTECH AMERICA, INC.
K130344 02/11/2013 DORNIER MEDILAS UROPULSE DORNIER MEDTECH AMERICA, INC.
K201074 04/22/2020 Delta III Lithotripter Dornier MedTech America, Inc.
K151485 06/02/2015 GENESIS DORNIER MEDTECH AMERICA, INC.
K121656 06/05/2012 GEMINI LITHOTRIPTER DORNIER MEDTECH AMERICA, INC.
K161771 06/28/2016 Medilas H Laser Fibers DORNIER MEDTECH AMERICA, INC.
K121938 07/02/2012 MEDILAS H RFID LASER FIBER DORNIER MEDTECH AMERICA, INC.
K172084 07/10/2017 Delta III Lithotripter Dornier MedTech America, Inc.
K122159 07/20/2012 DORNIER MEDILAS H30 SOLVO DORNIER MEDTECH AMERICA, INC.
K152591 09/10/2015 Medilas H RFID Laser Fibers Dornier MedTech America, Inc.
K123385 11/02/2012 MEDILAS H LASER FIBERS DORNIER MEDTECH AMERICA, INC.
K133434 11/08/2013 GENESIS II DORNIER MEDTECH AMERICA, INC.
K122768 09/10/2012 GENESIS DORNIER MEDTECH AMERICA, INC.
K080959 04/03/2008 DORNIER MEDILAS D 30 LASER, MEDILAS D 1064 DORNIER MEDTECH AMERICA, INC.
K083258 11/04/2008 MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE DORNIER MEDTECH AMERICA, INC.
K083500 11/25/2008 MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE DORNIER MEDTECH AMERICA, INC.
K073427 12/06/2007 MEDILAS D FAMILY LASERS DORNIER MEDTECH AMERICA, INC.
K070123 01/16/2007 TCA 5R / 5S DORNIER MEDTECH AMERICA, INC.
K020339 02/01/2002 DORNIER DIODE LASER FAMILY MEDILAS D, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEM DORNIER MEDTECH AMERICA, INC.
K070536 02/26/2007 MEDILAS D FAMILY LASERS DORNIER MEDTECH AMERICA, INC.
K021724 05/24/2002 DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEMS DORNIER MEDTECH AMERICA, INC.
K061455 05/25/2006 DORNIER MEDILAS H 20 LASER DORNIER MEDTECH AMERICA, INC.
K022544 08/01/2002 DORNIER MEDILAS H LASER FIBER CABLES DORNIER MEDTECH AMERICA, INC.


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