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FDA-Approved lasers for LASIK

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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
VISX
- Star S4 & WaveScan WaveFront System 		P930016/S20
3/17/05		 Wavefront-guided LASIK: Mixed astigmatism from 1.0 to 5.0 D
VISX
- Star S4 & WaveScan WaveFront System 		P930016/S21
8/30/05		 Wavefront-guided LASIK: Myopia from -6.0 to -11.0 D with or without astigmatism up to -3.0 D
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.


FDA-Approved lasers for PRK and other refractive surgeries

Company and model

Approval number and date

Approved indications
(D = diopters)
Alcon
- LADARVision 		P970043
11/2/98 		PRK; Myopia from -1.0 to -10.0D with or without astigmatism less than -4.0D
Alcon
- Apex & Apex Plus 		P930034
10/25/95 		PRK; Myopia from -1.5 to -7.0D
Alcon
- 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
Alcon
- Apex Plus 		P930034/S12
10/21/99		 PRK; Hyperopia from +1.5 to +4.0D with or without astigmatism less than -1.0D
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
Refractec
- ViewPoint CK System 		P010018
4 /11/02 		Conductive keratoplasty; Hyperopia from +0.75 to +3.25D with or without astigmatism up to 0.75D
Refractec
- ViewPoint CK System 		P010018/S5
03/16/2004 		Conductive keratoplasty; Monovision in patients with presbyopia with or without hyperopia
Sunrise
- Hyperion 		P990078
6/30/00 		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
3/27/96 		PRK; Myopia from 0 to -6.0D
VISX
- Model B & C (Star & Star S2) 		P930016/S3
4/24/97 		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/S5
1/29/98 		PRK; Myopia from 0 to -12.0D with or without astigmatism from 0 to -4.0D
VISX
- Star S2 		P930016/S7
11/2/98 		PRK; Hyperopia from +1.0 to +6.0D
VISX
- Star S2 & S3 		P930016/S10
10/18/00 		PRK; Hyperopia from +0.5 to +5.0D with or without astigmatism +0.5 to +4.0D
VISX
- Star S2 & S3 		P930016/S13
3/19/01		 Add myopia blend zone; increase overall ablation zone from 6.5 to 8.0mm

Military Position on Refractive Surgery

U.S. Federal Aviation Administration Policy on LASIK

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