FDA 510(k) Applications Submitted by MAUREEN O'CONNELL

FDA 510(k) Number Submission Date Device Name Applicant
K090009 01/02/2009 THD SLIDE ONE THD SPA
K990014 01/04/1999 DIOSCAN DIOMED, INC.
K070112 01/11/2007 RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM MEDCOOL INC
K020151 01/16/2002 UD-1000 ULTRASONIC A/B SCANNER TOMEY CORP. USA
K080248 01/31/2008 SPECTRA VRMIII Q-SWITCHED ND: YAG LASER SYSTEM AND DYE HANDPIECES LUTRONIC CORPORATION
K180265 01/31/2018 COMPACT TOUCH Ophthalmic Ultrasound System Quantel Medical
K130289 02/05/2013 TRC-NW8 NON-MYDRIATIC RETINAL CAMERA TOPCON CORP.
K070392 02/09/2007 MOSAIC LASER SYSTEM LUTRONIC CORPORATION
K030426 02/10/2003 OMNILUX RED PHOTO THERAPEUTICS LIMITED
K140336 02/10/2014 OPTIMUS FUSION: SLT, YAG AND YAG/SLT QUANTEL MEDICAL
K140368 02/14/2014 FAMILY OF DISPOSABLE LENSES SENSOR MEDICAL TECHNOLOGY, LLC
K040384 02/17/2004 MYDON C WAVELIGHT LASER TECHNOLOGIE AG
K040433 02/19/2004 SINON WAVELIGHT LASER TECHNOLOGIE AG
K080496 02/22/2008 MOSAIC ECO2 LASER SYSTEM LUTRONIC CORPORATION
K110489 02/22/2011 SLIT LAMP SL-2G TOPCON MEDICAL SYSTEMS, INC.
K130453 02/22/2013 EXCELSIOR EYEKOR, LLC.
K100610 03/03/2010 LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS LUTRONIC CORPORATION
K080638 03/06/2008 CLARO CLRS TECHNOLOGY CORPORATION
K120825 03/19/2012 SUPRA SCAN DELIVERY SYSTEM QUANTEL MEDICAL
K030883 03/20/2003 OMNILUX BLUE PHOTO THERAPEUTICS LIMITED
K090744 03/20/2009 CLARO CLRS TECHNOLOGY CORPORATION
K981090 03/26/1998 LASERLITE DIODE SURGICAL LASER LASERLITE, LLC.
K070815 03/26/2007 THD G.F. S.R.L.
K000982 03/27/2000 A100 AESTHETIC DIODE LASER DIOMED, INC.
K080932 04/02/2008 MOSAIC LASER SYSTEM LUTRONIC CORPORATION
K130933 04/04/2013 SOLUTIS QUANTEL MEDICAL
K060948 04/06/2006 PORTRAIT PSR3 RHYTEC INCORPORATED
K140929 04/09/2014 Z1 CPAP SYSTEM HUMAN DESIGN MEDICAL, LLC
K140924 04/11/2014 STARCERAM H.C. STARCK CERAMICS GMBH
K091115 04/17/2009 ECO2 LASER SYSTEM LUTRONIC CORPORATION
K091320 05/05/2009 SPECTRA SP II, SPECTRA DENTA II LUTRONIC CORPORATION
K121374 05/07/2012 ZI BLOWER DESHUM MEDICAL
K981640 05/08/1998 S2LO ODYSSEY OPTICAL SYSTEMS, LLC.
K231466 05/19/2023 RxSight Insertion Device RxSight, Inc.
K141325 05/20/2014 TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA TOPCON CORP.
K081429 05/21/2008 THD SLIDE THD SPA
K181401 05/29/2018 RxSight Insertion Device RxSight, Inc.
K091615 06/03/2009 MED CONTOUR GENERAL PROJECT S.R.L.
K141481 06/04/2014 TRC-NW400 NON-MYDRIATIC RETINAL CAMERA TOPCON CORPORATION
K051508 06/07/2005 MED FLASH II INTENSE PULSED LIGHT SYSTEM. GENERAL PROJECT S.R.L.
K101573 06/07/2010 ACCUSCULPT II LASER SYSTEM LUTRONIC CORPORATION
K101769 06/24/2010 EPISIL CAMURUS AB
K201909 07/09/2020 RxSight Contact Lens RxSight, Inc.
K062014 07/17/2006 FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB FLAEM NUOVA S.P.A.
K062015 07/17/2006 CHRONOS VISION EYE TRACKING DEVICE (C-ETD) CHRONOS VISION
K041957 07/21/2004 EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS DIOMED, INC.
K082096 07/24/2008 POWERLIPO LASER SYSTEM LUTRONIC CORPORATION
K012398 07/27/2001 DIOMED 15 DIODE LASER DIOMED, LTD.
K122251 07/27/2012 VITRA MULTISPOT QUANTEL MEDICAL
K072156 08/03/2007 OPTIMUS 0.035 INCH PTA BALLOON DILATATION CATHETER USCI IRELAND
K132438 08/05/2013 IMAGENET 5 PC SOFTWARE SYSTEM TOPCON MEDICAL SYSTEMS, INC.
K072163 08/06/2007 HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5 3A HEALTH CARE S.R.L.
K012803 08/21/2001 AL-2000 COMBINED BIOMETER AND PACHYMETER TOMEY CORP.
K062484 08/25/2006 FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS FLAEM NUOVA S.P.A.
K132667 08/27/2013 SYNERGY ODM TOPCON MEDICAL SYSTEMS, INC.
K032735 09/04/2003 SPECTRA QT: Q-SWITCHED ND: YAG LASER SYSTEM MAX ENGINEERING LTD.
K082646 09/11/2008 OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER USCI IRELAND
K102645 09/13/2010 WILLOW/ELM PTA BALLOON DILATATION CATHETER CREAGH MEDICAL LTD
K132976 09/23/2013 ADVATX ADVALIGHT APS
K123101 10/04/2012 TRC-50DX RETINAL CAMERA TOPCON MEDICAL SYSTEMS, INC.
K192926 10/16/2019 RxSight Insertion Device RxSight, Inc.
K133213 10/18/2013 STARCERAM H.C. STARCK CERAMICS GMBH
K093313 10/22/2009 SYNERGY TOPCON MEDICAL SYSTEMS, INC.
K083142 10/23/2008 PICASSO LASER SYSTEM AMD LASERS, LLC
K053041 10/27/2005 MED SCULPT GENERAL PROJECT S.R.L.
K043063 11/05/2004 OXYBAND WOUND DRESSING OXYBAND TECHNOLOGIES, INC.
K113468 11/22/2011 ELM PTA BALLON DILATATION CATHETER CREAGH MEDICAL LTD
K113502 11/25/2011 ADVANTAGE LASER SYSTEM LUTRONIC CORPORATION
K133667 11/29/2013 SLIT LAMP SL-D701 TOPCON CORP.
K073436 12/06/2007 SPECTRA VRMII 1-SWITCHED ND:YAG LASER SYSTEM LUTRONIC CORPORATION
K143561 12/16/2014 ELM PTA Balloon Dilatation Catheter O'CONNELL REGULATORY CONSULTANTS, INC.


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