Lasik

 

Lasik Details

Comprehensive Lasik Information            

 
     
 
  

 

 

 

 


 

 

Lasik Lasers

 

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
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.
 

 

 
  

 

 

 

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