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July 6, 2017 |
The STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System is indicated for Wavefront-guided laser assisted in situ keratomileusis (LASIK) in patients: 1) with hyperopia with and without astigmatism as measured by iDesign® Advanced WaveScan Studio System up to +4.00 D spherical equivalent, with up to 2.00 D cylinder; | AMO Manufacturing USA LLC | Labeling
Approval Order,
Summary of Safety and Effectiveness |
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May 6, 2015 |
STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System | AMO Manufacturing USA LLC | Labeling
Approval Order,
Summary of Safety and Effectiveness |
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September 30, 2013 |
Nidek EC-5000 Excimer Laser System | Nidek, Inc. | Labeling,
Approval Order,
Summary of Safety and Effectiveness |
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September 27, 2013 |
Allegretto WAVE® Eye-Q Excimer Laser System | Alcon Laboratories, Inc. | Labeling,
Approval Order,
Summary of Safety and Effectiveness |
| March 28, 2011 |
MEDITEC MEL 80 Excimer Laser System | Carl Zeiss, Inc. | Labeling,
Approval Order,
Summary of Safety and Effectiveness |
| July 11, 2007 |
Star S4 IR Excimer Laser System with Wavescan System | VISX, Inc. | Labeling,
Approval Order,
Summary of Safety and Effectiveness |
| October 11, 2006 |
Nidek EC-5000 Excimer Laser System | Nidek, Inc. | Labeling,
Approval Order,
Summary of Safety and Effectiveness |
| August 11, 2006 |
MEL 80 Excimer Laser System | Carl Zeiss, Inc. | Labeling,
Approval Order,
Summary of Safety and Effectiveness |
| July 26, 2006 |
WaveLight Allegretto Wave Excimer Laser System | Wavelight AG | Labeling,
Approval Order,
Summary of Safety and Effectiveness |
| May 2, 2006 |
LADARVision 4000 Excimer Laser System And the Ladar 6000 Excimer Laser System | Alcon Laboratories, Inc. | Labeling,
Approval Order,
Summary of Safety and Effectiveness |
| May 1, 2006 |
LADARVision 4000 Excimer Laser System | Alcon Laboratories, Inc. | Labeling,
Approval Order,
Summary of Safety and Effectiveness |
| April 19, 2006 |
WaveLight Allegretto Wave Excimer Laser System
| Wavelight AG | Labeling,
Approval Order,
Summary of Safety and Effectiveness |
| August 30, 2005 |
Star S4 IR Excimer Laser System with Variable Spot Scanning (Vss) and Wavescan Wavefront System | VISX, Inc. | Labeling,
Approval Order,
Summary of Safety and Effectiveness |
| March 17, 2005 |
Star S4 IR Excimer Laser System with Variable Spot Scanning (Vss) | VISX, Inc. | Labeling,
Approval Order,
Summary of Safety and Effectiveness |
| December 14, 2004 |
Star S4 Excimer Laser System with Variable Spot Scanning (Vss) and Wavescan Wavefront System | VISX, Inc. | Labeling,
Approval Order,
Summary of Safety and Effectiveness |
| June 29, 2004 |
LADARVision 4000 Excimer Laser System
| Alcon Laboratories, Inc. | Labeling,
Approval Order,
Summary of Safety and Effectiveness |
| October 10, 2003 |
Wavelight Allegretto Wave Excimer Laser System | Alcon Laboratories, Inc. | Labeling,
Approval Order,
Summary of Safety and Effectiveness |
| October 10, 2003 |
TECHNOLAS 217Z Zyoptix System for Personalized Vision Correction | Bausch & Lomb Surgical, Inc. | Labeling,
Approval Order,
Summary of Safety and Effectiveness |
| October 7, 2003 |
WaveLight Allegretto Wave Excimer Laser System | Alcon Laboratories, Inc | Labeling,
Approval Order,
Summary of Safety and Effectiveness |
| May 23, 2003 |
Star S4 Activetrak Excimer Laser System and Wavescan Wavefront System
| VISX, Inc. | Labeling,
Approval Order,
Summary of Safety and Effectiveness |
| February 25, 2003 |
TECHNOLAS 217A Excimer Laser System | Bausch & Lomb Surgical, Inc. | Labeling,
Approval Order,
Summary of Safety and Effectiveness |
| October 18, 2002 |
LADARVision 4000 Excimer Laser System
| Alcon Laboratories, Inc. | Labeling,
Approval Order,
Summary of Safety and Effectiveness |
| May 17, 2002 |
TECHNOLAS
217A Excimer Laser System | TECHNOLAS GMBH Perfect Vision | Labeling,
Approval Order,
Summary of Safety and Effectiveness |
| November 6, 2001 |
VISX Star Excimer Laser System | VISX, Inc. | Labeling,
Approval Order,
Summary of Safety and Effectiveness |
| September 28, 2001 |
Laserscan LSX Excimer Laser System for Laser Assisted In-situ Keratomileusis (LASIK) | Lasersight Technologies, Inc. | Labeling,
Approval Order,
Summary of Safety and Effectiveness |
| April 27, 2001 |
VISX Star Excimer Laser System | VISX, Inc. | Labeling,
Approval Order,
Summary of Safety and Effectiveness |
| September 22, 2000 |
LADARVision Excimer Laser System (Hyperopia) | Summit Autonomous, Inc. | Labeling,
Approval Order,
Summary of Safety and Effectiveness |
| May 9, 2000 |
LADARVision Excimer Laser System | Summit
Automonous, Inc. | Labeling,
Approval Order,
Summary of Safety and Effectiveness |
| April 14, 2000 |
Nidek EC-5000 Excimer Laser System
| Nidek Technologies, Inc | Labeling,
Approval Order,
Summary of Safety and Effectiveness |
| February 23, 2000 |
TECHNOLAS 217A Excimer Laser System | TECHNOLAS GMBH Perfect Vision | Labeling,
Approval Order,
Summary of Safety and Effectiveness |
| November 19, 1999 |
VISX Excimer Laser System Model C "Star" | AMO Manufacturing USA, LLC | Labeling,
Approval Order,
Summary of Safety and Effectiveness |
| October 21, 1999 |
SVS Apex Plus Excimer Laser Workstation | Summit Technology, Inc | Labeling,
Approval Order,
Summary of Safety and Effectiveness |
| July 30, 1998 |
Kremer Excimer Laser System | Lasersight Technologies, Inc. | Labeling,
Approval Order,
Summary of Safety and Effectiveness |
