Lasik Eye Surgery: FDA-Approved lasers for LASIK

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

Posted by RustedMan on Wednesday, January 03, 2007 at 4:13 AM | Permalink

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FDA-Approved lasers for LASIK

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