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)

<Lasik University

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 P930016/S13
3/19/01 Add myopia blend zone; increase overall ablation zone from 6.5 to 8.0mm

<Lasik University

Bausch & Lomb Hansetome™ Zero Compression Microkeratome

Bausch & Lomb Hansetome™ Zero Compression Microkeratome

<Lasik University

The microkeratome is the instrument that creates the corneal flap during the lasik surgery. Early on, microkeratomes were a complicated machine with many small components that required significant maintenance and assembly. These difficulties resulted in higher rates of lasik flap complications rarely seen today.

These complications includes poorly centered flaps, free flaps disconnected from the hinge, flaps that were to thin and too short. Also, the size of the flap was limited to 7-7.5mm.

The Bausch & Lomb Hansetome™ Zero Compression microkeratome allows the ability to create larger, thinner flaps- saving corneal tissue, creating less swelling and smoother flaps for quicker visual rehabilitation. The Zero Compression upgrade has been a significant step forward in preventing corneal abrasions (scratches on the surface of flap). In the past, the abrasion rate was high as 25%. With the Zero compression head it now less than 1%.

<Lasik University