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FDA-Approved Lasers for PRK and Other Refractive Surgeries

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 Name Company Approval Number
And Date		 Device or Consumer
Information / Instructions
STAR S4 IR Excimer Laser System and iDESIGN Refractive Studio AMO Manufacturing USA, LLC P930016/S57
September 9, 2019		 Labeling,
Approval Order,
Summary of Safety and Effectiveness
VisuMax Femtosecond Laser Carl Zeiss Meditec, Inc. P150040/S3
October 4, 2018		 Labeling,
Approval Order,
Summary of Safety and Effectiveness
WaveLight EX500 Excimer Laser System and Allegretto Wave Eye-Q Excimer Laser System Alcon Laboratories, Inc P020050/S23
November 21, 2016		 Labeling,
Approval Order,
Summary of Safety and Effectiveness
VisuMax Femtosecond Laser Carl Zeiss Meditec, Inc P150040
September 13, 2016		 Labeling,
Approval Order,
Summary of Safety and Effectiveness
VISX Star S2 and S3 Excimer Laser System VISX, Inc P930016/10
October 18, 2000		 Labeling,
Approval Order,
Summary of Safety and Effectiveness
Laserscan LSX Excimer Laser System Lasersight Technologies, Inc. P980008
November 12, 1999		 Labeling,
Approval Order,
Summary of Safety and Effectiveness
SVS Apex Plus Excimer Laser Workstation Summit Technology, Inc. P930034/S12
October 21, 1999		 Labeling,
Approval Order,
Summary of Safety and Effectiveness
Nidek EC-5000 Excimer Laser System (Park) Nidek Technologies, Inc P970053/S1
September 29, 1999		 Labeling,
Approval Order,
Summary of Safety and Effectiveness
KERACor 116
Ophthalmic Excimer Laser System		 Bausch and Lomb Surgical P970056
September 28, 1999		 Labeling,
Approval Order,
Summary of Safety and Effectiveness
EC-5000 Excimer Laser System Nidek, Inc. P970053
December 17, 1998		 Labeling,
Approval Order,
Summary of Safety and Effectiveness
LADARVision Excimer Laser System
 		 Alcon Laboratories P970043
November 2, 1998		 Labeling,
Approval Order,
Summary of Safety and Effectiveness
VISX Star S2 Excimer Laser System VISX, Inc. P930016/S7
November 2, 1998		 Labeling,
Approval Order,
Summary of Safety and Effectiveness
SVS Apex Plus Excimer Laser Workstation and Emphasis Disc Summit Technology, Inc. P930034/S9
March 11, 1998		 Labeling,
Approval Order,
Summary of Safety and Effectiveness
VISX Excimer Laser System Models “B” and “C” VISX, Inc. P930016/S5
January 29, 1998		 Labeling,
Approval Order,
Summary of Safety and Effectiveness
VISX Excimer Laser System Models “B” and “C” VISX, Inc. P930016/S3
April 24, 1997		 Labeling,
Approval Order,
Summary of Safety and Effectiveness
VISX Excimer Laser System Models “B” and “C” AMO Manufacturing USA, LLC P930016
March 27, 1996		 Labeling,
Approval Order,
Summary of Safety and Effectiveness
SVS Apex Excimer Laser System Summit Technology, Inc. P930034
October 20, 1995		 Labeling,
Approval Order,
Summary of Safety and Effectiveness
VISX Model B /Model C Excimer Laser System AMO Manufacturing USA, LLC P910062
September 29, 1995		 Labeling,
Approval Order,
Summary of Safety and Effectiveness
Eximed UV200LA Excimer Laser System SVS Apex Excimer Laser System Summit Technology, Inc. P910067
March 10, 1995		 Labeling,
Approval Order,
Summary of Safety and Effectiveness

 

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