FDA Approved Lasers for Lasik Eye Surgery
Source:
http://www.fda.gov/cdrh/LASIK/lasers.htm
|
Company and model
|
Approval number and date
|
Approved indications
|
|---|---|---|
| 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 |
| 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. |