Medical Devices

List of FDA-Approved Lasers for LASIK

The Device Name for a particular laser will connect you to another FDA page that will give you a summary of this submission. The labeling under Device or Consumer Information/Instructions is often combined into one document with the patient labeling following the physician labeling.

Device NameCompanyApproval Number
And Date
Device or Consumer
Information / Instructions
Nidek EC-5000 Excimer Laser System Nidek, Inc.P970053/S11
September 30, 2013
Labeling,
Approval Order,
Summary of Safety and Effectiveness
Allegretto WAVE® Eye-Q Excimer Laser System Alcon Laboratories, Inc.P020050/S12
September 27, 2013
Labeling,
Approval Order,
Summary of Safety and Effectiveness
MEDITEC MEL 80 Excimer Laser System Carl Zeiss, Inc.P060004/S1
March 28, 2011
Labeling,
Approval Order,
Summary of Safety and Effectiveness
Star S4 IR Excimer Laser System with Wavescan SystemVISX, Inc.P930016/S25
July 11, 2007
Labeling,
Approval Order,
Summary of Safety and Effectiveness
Nidek EC-5000 Excimer Laser SystemNidek, Inc.P970053/S9
October 11, 2006
Labeling,
Approval Order,
Summary of Safety and Effectiveness
MEL 80 Excimer Laser SystemCarl Zeiss, Inc.P060004
August 11, 2006
Labeling,
Approval Order,
Summary of Safety and Effectiveness
WaveLight Allegretto Wave Excimer Laser SystemWavelight AGP020050/S4
July 26, 2006
Labeling,
Approval Order,
Summary of Safety and Effectiveness
LADARVision 4000 Excimer Laser System And the Ladar 6000 Excimer Laser SystemAlcon Laboratories, Inc.P970043/S22
May 2, 2006
Labeling,
Approval Order,
Summary of Safety and Effectiveness
LADARVision 4000 Excimer Laser SystemAlcon Laboratories, Inc.P970043/S20
May 1, 2006
Labeling,
Approval Order,
Summary of Safety and Effectiveness
WaveLight Allegretto Wave Excimer Laser System
 
Wavelight AGP030008/S4
April 19, 2006
Labeling,
Approval Order,
Summary of Safety and Effectiveness
Star S4 IR Excimer Laser System with Variable Spot Scanning (Vss) and Wavescan Wavefront SystemVISX, Inc.P930016/S21
August 30, 2005
Labeling,
Approval Order,
Summary of Safety and Effectiveness
Star S4 IR Excimer Laser System with Variable Spot Scanning (Vss)VISX, Inc.P930016/S20
March 17, 2005
Labeling,
Approval Order,
Summary of Safety and Effectiveness
Star S4 Excimer Laser System with Variable Spot Scanning (Vss) and Wavescan Wavefront SystemVISX, Inc.P930016/S17
December 14, 2004
Labeling,
Approval Order,
Summary of Safety and Effectiveness
LADARVision 4000 Excimer Laser System
 
Alcon Laboratories, Inc.P970043/S15
June 29, 2004
Labeling,
Approval Order,
Summary of Safety and Effectiveness
Wavelight Allegretto Wave Excimer Laser SystemAlcon Laboratories, Inc.P030008
October 10, 2003
Labeling,
Approval Order,
Summary of Safety and Effectiveness
TECHNOLAS 217Z Zyoptix System for Personalized Vision CorrectionBausch & Lomb Surgical, Inc.P990027/S6
October 10, 2003
Labeling,
Approval Order,
Summary of Safety and Effectiveness
WaveLight Allegretto Wave Excimer Laser SystemAlcon Laboratories, IncP020050
October 7, 2003
Labeling,
Approval Order,
Summary of Safety and Effectiveness
Star S4 Activetrak Excimer Laser System and Wavescan Wavefront System
 
VISX, Inc.P930016/S16
May 23, 2003
Labeling,
Approval Order,
Summary of Safety and Effectiveness
TECHNOLAS 217A Excimer Laser SystemBausch & Lomb Surgical, Inc.P990027/S4
February 25, 2003
Labeling,
Approval Order,
Summary of Safety and Effectiveness
LADARVision 4000 Excimer Laser System
 
 
Alcon Laboratories, Inc.P970043/S10
October 18, 2002
Labeling,
Approval Order,
Summary of Safety and Effectiveness
TECHNOLAS
217A Excimer Laser System
TECHNOLAS GMBH Perfect VisionP990027/S2
May 17, 2002
Labeling,
Approval Order,
Summary of Safety and Effectiveness
VISX Star Excimer Laser SystemVISX, Inc.P930016/S14
November 6, 2001
Labeling,
Approval Order,
Summary of Safety and Effectiveness
Laserscan LSX Excimer Laser System for Laser Assisted In-situ Keratomileusis (LASIK)Lasersight Technologies, Inc.P980008/S5
September 28, 2001
Labeling,
Approval Order,
Summary of Safety and Effectiveness
VISX Star Excimer Laser SystemVISX, Inc.P930016/S12
April 27, 2001
Labeling,
Approval Order,
Summary of Safety and Effectiveness
LADARVision Excimer Laser System (Hyperopia)Summit Autonomous, Inc.P970043/S7
September 22, 2000
Labeling,
Approval Order,
Summary of Safety and Effectiveness
LADARVision Excimer Laser SystemSummit
Automonous, Inc.
P970043/S5
May 9, 2000
Labeling,
Approval Order,
Summary of Safety and Effectiveness
Nidek EC-5000 Excimer Laser System
 
 
Nidek Technologies, IncP970053/S2
April 14, 2000
Labeling,
Approval Order,
Summary of Safety and Effectiveness
TECHNOLAS 217A Excimer Laser SystemTECHNOLAS GMBH Perfect VisionP990027
February 23, 2000
Labeling,
Approval Order,
Summary of Safety and Effectiveness
VISX Excimer Laser System Model C “Star”AMO Manufacturing USA, LLCP990010
November 19, 1999
Labeling,
Approval Order,
Summary of Safety and Effectiveness
SVS Apex Plus Excimer Laser WorkstationSummit Technology, IncP930034/S13
October 21, 1999
Labeling,
Approval Order,
Summary of Safety and Effectiveness
Kremer Excimer Laser SystemLasersight Technologies, Inc.P970005
July 30, 1998
Labeling,
Approval Order,
Summary of Safety and Effectiveness

Page Last Updated: 06/13/2014
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