Lasik Eye Surgery

LASIK is a surgical procedure intended to reduce a person's dependency on glasses or contact lenses.

FDA-Approved lasers for LASIK 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 model Approval number and date Approved indications (D = diopters) Alcon - LADARVision P970043/S5 5/9/00 Myopia less than -9.0D with or without astigmatism from -0.5 to -3.0D Alcon - LADARVision P970043/S7 9/22/00 Hyperopia less than 6.0D with or without astigmatism less than -6.0D Alcon - LADARVision P970043/S10 10/18/02 Wavefront-guided LASIK: Myopia up to -7.0D with or without astigmatism less than 0.5D Alcon - LADARVision P970043/S15 6/29/04 Wavefront-guided LASIK: Myopic astigmatism from -0.5D to -4.0D Alcon - Apex Plus P930034/S13 10/21/99 Myopia less than -14.0D with or without astigmatism from 0.5 to 5.0D Bausch & Lomb Surgical - Technolas 217a P990027 2/23/00 Myopia from -1.0 to -7.0D with or without astigmatism less than -3.0D Bausch & Lomb Surgical - Technolas 217a P990027/S2 5/15/02 Myopia less than -11D with or without astigmatism less than -3.0D Bausch & Lomb Surgical - Technolas 217a P990027/S4 2/25/03 Hyperopia between 1.0 and 4.0D with or without astigmatism up to 2.0D Bausch & Lomb Surgical - Technolas 217z P990027/S6 10/10/03 Wavefront-guided LASIK: Myopia up to -7.0D with or without astigmatism up to -3.0D Dishler P970049 12/16/99 Myopia from -0.5 to -13.0D with or without astigmatism between -0.5 to -4.0D Kremer P970005 7/30/98 Myopia from -1.0 to -15.0D with or without astigmatism up to -5.0D LaserSight - LaserScan LSX P980008/S5 9/28/01 Myopia from -0.5 to -6.0D with or without astigmatism up to 4.5D Nidek - EC5000 P970053/S2 4/14/00 Myopia from -1.0 to -14.0D with or without astigmatism less than 4.0D VISX - Star S2 & S3 P930016/S12 4/27/01 Hyperopia between +0.5 and +5.0D with or without astigmatism up to +3.0D VISX - Star S2 & S3 P930016/S14 11/16/01 Mixed astigmatism up to 6.0D; cylinder is greater than sphere and of opposite sign VISX - Star S2 P990010 11/19/99 Myopia less than -14.0D with or without astigmatism between -0.5 and -5.0D VISX - Star S3 (EyeTracker) P990010/S1 4/20/00 Same as S2, except with eye tracker VISX - Star S4 & WaveScan WaveFront System P930016/S16 5/23/03 Wavefront-guided LASIK: Myopia up to -6.0D with or without astigmatism up to -3.0D VISX - Star S4 & WaveScan WaveFront System P930016/S17 12/14/04 Wavefront-guided LASIK: Hyperopia up to +3.00D with or without astigmatism up to +2.00D VISX - Star S4 & WaveScan WaveFront System P930016/S20 3/17/05 Wavefront-guided LASIK: Mixed astigmatism from 1.0 to 5.0 D VISX - Star S4 & WaveScan WaveFront System P930016/S21 8/30/05 Wavefront-guided LASIK: Myopia from -6.0 to -11.0 D with or without astigmatism up to -3.0 D WaveLight - ALLEGRETTO WAVE P020050 10/07/03 Myopia up to -12.0D with or without astigmatism up to -6.0D. WaveLight - ALLEGRETTO WAVE P030008 10/10/03 Hyperopia up to +6.0D with or without astigmatism up to +5.0D.

FDA-Approved lasers for PRK and other refractive surgeries Company and model Approval number and date Approved indications (D = diopters) Alcon - LADARVision P970043 11/2/98 PRK; Myopia from -1.0 to -10.0D with or without astigmatism less than -4.0D Alcon - Apex & Apex Plus P930034 10/25/95 PRK; Myopia from -1.5 to -7.0D Alcon - Apex Plus P930034/S9 3/11/98 PRK; Myopia from -1.0 to -6.0D with or without astigmatism from -1.0 to -4.0D Alcon - Apex Plus P930034/S12 10/21/99 PRK; Hyperopia from +1.5 to +4.0D with or without astigmatism less than -1.0D Bausch & Lomb Surgical - KERACOR 116 P970056 9/28/99 PRK; Myopia from -1.5 to -7.0D with or without astigmatism less than -4.5D LaserSight - LaserScan LSX P980008 11/12/99 PRK; Myopia from -1.0 to -6.0D with or without astigmatism less than 1.0D Nidek - EC5000 P970053 12/17/98 PRK; Myopia from -0.75 to -13.0D Nidek - EC5000 P970053/S1 9/29/99 PRK; Myopia from -1.0 to -8.0D with or without astigmatism from -0.5 to -4.0D Refractec - ViewPoint CK System P010018 4 /11/02 Conductive keratoplasty; Hyperopia from +0.75 to +3.25D with or without astigmatism up to 0.75D Refractec - ViewPoint CK System P010018/S5 03/16/2004 Conductive keratoplasty; Monovision in patients with presbyopia with or without hyperopia Sunrise - Hyperion P990078 6/30/00 Laser 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 3/27/96 PRK; Myopia from 0 to -6.0D VISX - Model B & C (Star & Star S2) P930016/S3 4/24/97 PRK; Myopia from 0 to -6.0D with or without astigmatism from -0.75 to -4.0D VISX - Model B & C (Star & Star S2) P930016/S5 1/29/98 PRK; Myopia from 0 to -12.0D with or without astigmatism from 0 to -4.0D VISX - Star S2 P930016/S7 11/2/98 PRK; Hyperopia from +1.0 to +6.0D VISX - Star S2 & S3 P930016/S10 10/18/00 PRK; Hyperopia from +0.5 to +5.0D with or without astigmatism +0.5 to +4.0D VISX - Star S2 & S3 P930016/S13 3/19/01 Add myopia blend zone; increase overall ablation zone from 6.5 to 8.0mm