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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
WaveLight EX500 Laser    Alcon Laboratories, Inc.P020050/S043 
March 5, 2025		Labeling, 
Approval Order, 
Summary of Safety and Effectiveness
 
MEL90Carl Zeiss Meditec, Inc.P060004/S006
December 5, 2024		Labeling, 
Approval Order, 
Summary of Safety and Effectiveness
 
TECHNOLAS TENEO 317 (MODEL 2) Excimer Laser SystemTECHNOLAS PERFECT VISION GMBHP990027/S021
November 22, 2023		Labeling, 
Approval Order, 
Summary of Safety and Effectiveness
 
iDESIGNRefractive Studio, STAR Excimer Laser SystemAMO Manufacturing USA, LLCP930016/S053
June 15, 2018		Labeling,
Approval Order,
Summary of Safety and Effectiveness
STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio SystemAMO Manufacturing USA LLCP930016/S048
June 30, 2017		Labeling,
Approval Order,
Summary of Safety and Effectiveness
STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio Indication SystemAMO Manufacturing USA LLCP930016/S45
November 14, 2016		Labeling,
Approval Order,
Summary of Safety and Effectiveness
STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio SystemAMO Manufacturing USA LLCP930016/S044
May 6, 2015		Labeling,
Approval Order,
Summary of Safety and Effectiveness
Nidek EC-5000 Excimer Laser SystemNidek, Inc.P970053/S11
September 30, 2013		Labeling,
Approval Order,
Summary of Safety and Effectiveness
Allegretto WAVE® Eye-Q Excimer Laser SystemAlcon Laboratories, Inc.P020050/S12
September 27, 2013		Labeling,
Approval Order,
Summary of Safety and Effectiveness
MEDITEC MEL 80 Excimer Laser SystemCarl 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 SystemVISX, 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

 

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