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. |