The Laser
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) |
| AutonomousTechnology - LADARVision | P970043/S5 5/9/00 | Myopia less than -9.0D with or without astigmatism from -0.5 to -3.0D |
| 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 |
| 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 |
| Summit - Apex Plus | P930034/S13 10/21/99 | Myopia less than -14.0D with or without astigmatism from 0.5 to 5.0D |
| Summit Autonomous - LADARVision | P970043/S7 9/22/00 | Hyperopia less than 6.0D with or without astigmatism less than -6.0D |
| 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 |
| Autonomous Technology - LADARVision | P970043 11/2/98 | PRK ; Myopia from -1.0 to -10.0D with or without astigmatism less than -4.0D |
| 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 |
| Summit - Apex & Apex Plus | P930034 10/25/95 | PRK ; Myopia from -1.5 to -7.0D |
| Summit - 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 |
| Summit - Apex Plus | P930034/S12 10/21/99 | PRK ; Hyperopia from +1.5 to +4.0D with or without astigmatism less than -1.0D |
| Summit Autonomous - LADARVision | P970043/S8 7/11/00 | Name Change Only |
| Sunrise - Hyperion | P930016 3/27/96 | 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/S3 4/24/97 | PRK ; Myopia from 0 to -6.0D |
| VISX - Model B & C (Star & Star S2) | P930016/S5 1/29/98 | 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/S7 11/2/98 | PRK ; Myopia from 0 to -12.0D with or without astigmatism from 0 to -4.0D |
| VISX - Star S2 | P930016/S10 10/18/00 | PRK ;Hyperopia from +1.0 to +6.0D |
| VISX - Star S2 & S3 | P930016/S13 3/19/01 | PRK ; Hyperopia from +0.5 to +5.0D with or without astigmatism +0.5 to +4.0D |
U.S. Food and Drug Administration, Center for Devices and Radiological Health