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FDA-Approved lasers for LASIK


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Approval Number for a particular laser will connect you to another FDA page with links to the Approval Order, Indications for Use, the Summary of Safety and Effectiveness (SSE) and the Labeling for Physician and Patient (labeling is often combined into one document with the patient labeling following the physician labeling).

Company and modelApproval number and dateApproved indications (D = diopters)
AutonomousTechnology - LADARVisionP970043/S5 5/9/00Myopia less than -9.0D with or without astigmatism from -0.5 to -3.0D
Bausch& Lomb Surgical - Technolas 217aP990027 2/23/00Myopia from -1.0 to -7.0D with or without astigmatism less than – ;3.0D
Bausch & Lomb Surgical - Technolas 217aP990027/S2 5/15/02Myopia less than -11D with or without astigmatism less than – 3.0D
DishlerP970049 12/16/99Myopia from -0.5 to -13.0D with or without astigmatism between -0.5 to -4.0D
KremerP970005 7/30/98Myopia from -1.0 to -15.0D with or without astigmatism up to -5.0D
LaserSight - LaserScan LSXP980008/S5 9/28/01Myopia from -0.5 to -6.0D with or without astigmatism up to 4.5D
Nidek - EC5000P970053/S2 4/14/00Myopia from -1.0 to -14.0D with or without astigmatism less than 4.0D
Summit - Apex PlusP930034/S13 10/21/99Myopia less than -14.0D with or without astigmatism from 0.5 to 5.0D
Summit Autonomous - LADARVisionP970043/S7 9/22/00Hyperopia less than 6.0D with or without astigmatism less than -6.0D
VISX - Star S2 & S3P930016/S12 4/27/01Hyperopia between +0.5 and +5.0D with or without astigmatism up to +3.0D
VISX - Star S2 & S3P930016/S14 11/16/01Mixed astigmatism up to 6.0D ; cylinder is greater than sphere and of opposite sign
VISX - Star S2P990010 11/19/99Myopia less than -14.0D with or without astigmatism between -0.5 and -5.0D
VISX - Star S3 (EyeTracker)P990010/S1 4/20/00Same as S2, except with eye tracker
Autonomous Technology - LADARVisionP970043 11/2/98PRK ; Myopia from -1.0 to -10.0D with or without astigmatism less than -4.0D
Bausch & Lomb Surgical - KERACOR 116P970056 9/28/99PRK ; Myopia from -1.5 to -7.0D with or without astigmatism less than -4.5D
LaserSight - LaserScan LSXP980008 11/12/99PRK ; Myopia from -1.0 to -6.0D with or without astigmatism less than 1.0D
Nidek - EC5000P970053 12/17/98PRK ; Myopia from -0.75 to -13.0D
Nidek - EC5000P970053/S1 9/29/99PRK ; Myopia from -1.0 to -8.0D with or without astigmatism from -0.5 to -4.0D
Summit - Apex & Apex PlusP930034 10/25/95PRK ; Myopia from -1.5 to -7.0D
Summit - Apex PlusP930034/S9 3/11/98PRK ; Myopia from -1.0 to -6.0D with or without astigmatism from -1.0 to -4.0D
Summit - Apex PlusP930034/S12 10/21/99PRK ; Hyperopia from +1.5 to +4.0D with or without astigmatism less than -1.0D
Summit Autonomous - LADARVisionP970043/S8 7/11/00Name Change Only
Sunrise - HyperionP930016 3/27/96Laser Thermokeratoplasty (LTK) ; Hyperopia from +0.75 to +2.5D with or without astigmatism less than 0.75D
VISX - Model B & C (Star & Star S2)P930016/S3 4/24/97PRK ; Myopia from 0 to -6.0D
VISX - Model B & C (Star & Star S2)P930016/S5 1/29/98PRK ;Myopia from 0 to -6.0D with or without astigmatism from -0.75 to -4.0D
VISX - Model B & C (Star & Star S2)P930016/S7 11/2/98PRK ; Myopia from 0 to -12.0D with or without astigmatism from 0 to -4.0D
VISX - Star S2P930016/S10 10/18/00PRK ;Hyperopia from +1.0 to +6.0D
VISX - Star S2 & S3P930016/S13 3/19/01PRK ; Hyperopia from +0.5 to +5.0D with or without astigmatism +0.5 to +4.0D

Source: U.S. Food and Drug Administration, Center for Devices and Radiological Health


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