Company and model | Approval number and date | Approved indications
(D = diopters) |
Alcon
- LADARVision | P970043/S10
10/18/02 | Wavefront-guided LASIK: Myopia up to -7.0D with or without astigmatism less than 0.5D |
Autonomous Technology
- 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 |
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 |
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 |
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 |
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. |
