FDA-Approved Lasers for LASIK


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LASIK Technologies Patient Booklets

Approval Number
And Date
Device NameCompanyDevice or Consumer
Information / Instructions
May 6, 2015 STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio SystemAMO Manufacturing USA LLC

Labeling
Approval Order,
Summary of Safety and Effectiveness

September 30, 2013 Nidek EC-5000 Excimer Laser System Nidek, Inc.Labeling,
Approval Order,
Summary of Safety and Effectiveness
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 SystemVISX, Inc.Labeling,
Approval Order,
Summary of Safety and Effectiveness
October 11, 2006 Nidek EC-5000 Excimer Laser SystemNidek, Inc.Labeling,
Approval Order,
Summary of Safety and Effectiveness
August 11, 2006 MEL 80 Excimer Laser SystemCarl Zeiss, Inc.Labeling,
Approval Order,
Summary of Safety and Effectiveness
July 26, 2006 WaveLight Allegretto Wave Excimer Laser SystemWavelight AGLabeling,
Approval Order,
Summary of Safety and Effectiveness
May 2, 2006 LADARVision 4000 Excimer Laser System And the Ladar 6000 Excimer Laser SystemAlcon Laboratories, Inc.Labeling,
Approval Order,
Summary of Safety and Effectiveness
May 1, 2006 LADARVision 4000 Excimer Laser SystemAlcon Laboratories, Inc.Labeling,
Approval Order,
Summary of Safety and Effectiveness
April 19, 2006 WaveLight Allegretto Wave Excimer Laser System
 
Wavelight AGLabeling,
Approval Order,
Summary of Safety and Effectiveness
August 30, 2005 Star S4 IR Excimer Laser System with Variable Spot Scanning (Vss) and Wavescan Wavefront SystemVISX, 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 SystemVISX, 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 SystemAlcon Laboratories, Inc.Labeling,
Approval Order,
Summary of Safety and Effectiveness
October 10, 2003 TECHNOLAS 217Z Zyoptix System for Personalized Vision CorrectionBausch & Lomb Surgical, Inc.Labeling,
Approval Order,
Summary of Safety and Effectiveness
October 7, 2003 WaveLight Allegretto Wave Excimer Laser SystemAlcon Laboratories, IncLabeling,
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 SystemBausch & 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 VisionLabeling,
Approval Order,
Summary of Safety and Effectiveness
November 6, 2001 VISX Star Excimer Laser SystemVISX, 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 SystemVISX, 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 SystemSummit
Automonous, Inc.
Labeling,
Approval Order,
Summary of Safety and Effectiveness
April 14, 2000 Nidek EC-5000 Excimer Laser System
 
 
Nidek Technologies, IncLabeling,
Approval Order,
Summary of Safety and Effectiveness
February 23, 2000 TECHNOLAS 217A Excimer Laser SystemTECHNOLAS GMBH Perfect VisionLabeling,
Approval Order,
Summary of Safety and Effectiveness
November 19, 1999 VISX Excimer Laser System Model C "Star"AMO Manufacturing USA, LLCLabeling,
Approval Order,
Summary of Safety and Effectiveness
October 21, 1999 SVS Apex Plus Excimer Laser WorkstationSummit Technology, IncLabeling,
Approval Order,
Summary of Safety and Effectiveness
July 30, 1998 Kremer Excimer Laser SystemLasersight Technologies, Inc.Labeling,
Approval Order,
Summary of Safety and Effectiveness


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