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U.S. Department of Health and Human Services

Medical Devices

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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
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