FDA Approved Lasers

FDA-Approved lasers for LASIK - Source Fda.gov

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.

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 VISX
- Star S2 & S3 P930016/S13
3/19/01 Add myopia blend zone; increase overall ablation zone from 6.5 to 8.0mm