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Hello and welcome to Lasik University where you can Learn about Lasik Eye Surgery from the Lasik inside. After personally facilitating well over 2,000 Lasik Eye Surgeries I have compiled vital information just for your review, a potential Lasik candidate, past Lasik patient, Lasik researcher or Lasik physician...

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Showing posts with label FDA Laser Approvals. Show all posts
Showing posts with label FDA Laser Approvals. Show all posts

FDA Approves New-Generation Laser for Corneal Flap Creation

The Food and Drug Administration has cleared the way for Advanced Medical Optics to begin selling its new-generation femtosecond laser. This laser is used to create a thin corneal flap on the eye's surface in preparation for the Lasik procedure.

In a Lasik Surgery, the laser will create a flap and it is then hinged back and then a different type of laser called an excimer laser is then used to reshape the cornea to achieve better vision.

Advanced Medical Optics newly approved laser that is known as the IFS Advanced Femtosecond Laser has advanced capabilities like the ability to complete a corneal flap in under ten seconds. This is phenomenal!

Some of the other exiting features is that it can create elliptiacal form flaps which will increase the options Lasik Eye Surgeons have to address individual vision concerns. It is really a boost in continuing the customization of the Lasik Procedure.

Lasik Counselor

FDA responds to Lasik Advisory Board

If you have already had Lasik or are interested in having Lasik you should be aware that the US Food and Drug Administration has now finally responded to a public advisory panel of outside Lasik industry professionals who have taken the time to hear about the experiences of Lasik patients. Together this public Lasik advisory panel is considering how to drastically improve the availability of good information for potential Lasik patients and Lasik physicians about Lasik.

The Food and Drug Administration has responded to public and Lasik expert feedback and is now implementing multiple improvements in communications with the public in regards to Lasik related safety concerns and issues.
Some of these improvements include keeping the FDA’s website more up to date to make it easier to report any Lasik problems to MedWatch, the government’s platform to receive complaints in regards to FDA approved medical instruments. Within the updated public information you will now see more of a focus on any reports of patients experiencing halos, glare, night vision problems and dry eye syndrome. These issues are very well known side-effects of Lasik Eye Surgery. To learn more about Lasik side-effects please visit Lasik911 .

Patient information cards are now being constructed with full partnership of the American Academy of Ophthalmology that Lasik Doctors can fill out with the patient’s exact eye measurements before their Lasik Procedure. Lasik Patients will be able to retain this information card to assist their Doctor in calculating the lens implant power in the event they require future cataract surgery.

It is great to see that the FDA is finally addressing some of the existing concerns about Lasik side-effects and the lack of good Lasik educational information.

To learn more about Lasik you can register for Lasik University for FREE!

Lasik Counselor

FDA Grants Mixed Astigmatism Approval to WaveLight

STERLING, Va., April 2007 — A new U.S Food and Drug Administration approval means WaveLight's Allegretto Wave Eye-Q excimer Laser System for wavefront-guided LASIK and other procedures now can be used to treat mixed astigmatism of up to 6.00 diopters.

A company statement says the FDA has granted four approvals in the past year, enabling an expanded range of vision correction treatments for the excimer laser, including up to -7.00 diopters of nearsightedness.

http://www.LasikUniversity.com


Lasik University

NIDEK Gains FDA Approval for Hyperopia and Hyperopic Astigmatism Module on EC-5000 Excimer Laser

Nidek is finally approved for Hyperopic treatment. Go to http://www.nideklaser.com to research the Nidek Laser.

Lasik University

Here is the press release:

FREMONT, Calif., Oct. 17, 2006 (PRIMEZONE) -- NIDEK, Inc. a global leader in laser and diagnostic instrumentation for the optical and eye care industry, announced today that the U.S. Food & Drug Administration (FDA) has approved its EC-5000 Excimer Laser for the treatment of hyperopia and hyperopic astigmatism for use in LASIK.

With this approval, ophthalmic surgeons are able to treat hyperopia and hyperopic astigmatism (+0.50D to +5.00D sphere and up to 2.00D cylinder) in addition to the current approved range for myopia and myopic astigmatism. Hyperopia or farsightedness may be surgically treated by laser vision correction or LASIK.

Mr. Motoki Ozawa, Vice President, NIDEK Co., Ltd stated, "This is a historic event for NIDEK and we are especially pleased to have this long-awaited approval. The excellent and outstanding results from 291 eyes demonstrate NIDEK's commitment to providing an innovative, technologically superior excimer platform for laser vision correction surgery. Furthermore, NIDEK is actively developing its own custom ablation and wavefront technology platform. The EC-5000 Excimer Laser System is a perfect pairing to NIDEK's strong, world-class product portfolio in unsurpassed diagnostic and surgical instrumentation, optical finishing and dispensing products in vision care."

The following chart demonstrates six month follow up results of the safety and effectiveness of the EC-5000 Hyperopia clinical results:

Six Month Follow Up Results (291 eyes)

69% within +/- 0.5 D
93% within +/- 1.0 D
60% 20/20 or better (UCVA)
86% 20/25 or better (UCVA)
99% 20/40 or better (UCVA)

About NIDEK

NIDEK is a global leader in diagnostic and surgical eye care products for ophthalmology and optometry focused on developing and delivering innovative technologies that enhance the quality of human life. With diversified clinical research and continual innovative development, an array of laser and optical scanning products offered that lead the way for improved diagnosis and treatments. The relentless commitment to customer satisfaction means NIDEK will diligently strive to continually exceed expectations. For more information, visit www.nideklaser.com.

Lasik University

MEL 80™ Excimer Laser "See Better Perfomance!"

Here is information on The Mel 80 Excimer Laser System,

Lasik University

Just what your clinic's
looking for
The MEL 80 is a top quality Carl Zeiss Meditec product, designed to make the correction of vision defects even safer, more patient-friendly and individual. All the parameters of this ultramodern work platform are oriented towards increasing efficiency, achieving optimum treatment results and the rapid recovery of vision. Key factors here are the extremely fast ablation, customized treatment planning with the optional CRS-Master, the high-performance eyetracker system and the "Eye Registration" torsion compensation system.

Better for the Eye
With the tiniest spot size and its Gaussian beam profile the MEL 80 produces matchless quality in corneal ablation - exact, even and protective of the surrounding tissue. Even in complex ablation procedures, the large overlap of the laser spot zones yields very smooth surfaces.
Two specially optimized ablation profiles help you produce excellent results:
ASA (Aberration Smart Ablation) – tried and tested strongly aspherical profiles, optimized for "mesopic vision"
TSA (Tissue Saving Algorithm) – the conservative tissue-saving alternative with lower asphericity for re-treatment and thin corneas
Safe use
The MEL 80 helps you significantly reduce the duration of treatment. This has the following benefits:
The stromal bed is only open for a short period; this prevents dehydration and speeds up the regeneration process
The thermally-optimized distribution of the laser firing pattern protects the stroma - despite the high ablation speed
Patients' stress is relieved; they only need to concentrate for a few seconds on the fixation light
Increased efficiency levels and number of patients you see
Everything's under control!
An active eyetracker with excellent feedback times and an ultrarapid IR camera provides exact positioning during the laser treatment. Thanks to automatic pupil recognition you can adjust the desired centering point within seconds. This also includes the limbus. If the center of the pupil shifts with relation to the limbus during ablation - through asymmetrical contraction, for instance - the eyetracker compensates for this. And what's more - no pupil-dilating medication (with its attendant waiting times) is necessary prior to this treatment

Greater customization
for your patients
Carl Zeiss has dedicated itself to constantly improving the customized ablation procedure. One successful result of this development is the CRS-Master. This system integrates the data from the wavefront diagnosis and the cornea topography in the MEL 80 and gives you full control over all treatment parameters at a glance.

*Not for sale in the United States or Japan.

Lasik University

For more research please visit http://www.lasik.fm

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

The FDA approved correction parameters for The Allegretto Wavelight Excimer Laser System!

Hi potential Lasik patients, Here are the FDA approved correction parameters for The Allegretto Wavelight Excimer Laser System. I recommend The Allegretto Wavelight Excimer Laser System.

<Lasik University

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.

Thank You,

The Lasik Counselor

Lasik University

Intralase Corp., Gets FDA approval for expanded use of the Intralase Laser

I have been a stockholder of Intralase the maker of the Intralase Femtosecond Laser which is the up and coming new way to create a corneal flap for the first step of Lasik for a while now. I recieved a news update from the company a few days ago that Intralase had recieved FDA approval for expanded uses for their patented laser. It is now approved to help people in the area of corneal transplants. Please read below a small portion of the news alert.

Nidek Laser Technolas Laser Ladar Laser Allegretto Laser Intralase Laser Hyperion Laser NearVision CK Visx Laser Mel 80 Laser Esiris Laser Laser Scan LSX Phasik
Lasik Links

The new application of the IntraLase FS30 laser is the direct result of the company's ongoing collaboration with the world's leading corneal surgeons to develop innovative techniques with and enhancements of the technology.
"This really opens up the door for additional uses of this extremely versatile device," said Roger Steinert, M.D., professor and vice chairman of the department of ophthalmology at the University of California, Irvine, and president of the American Society of Cataract and Refractive Surgeons. "In our initial clinical work, we found that the laser has the ability to create shaped, full-thickness corneal transplants that are much stronger than traditional penetrating keratoplasty transplants with less induction of astigmatism. In addition, transplants created with the laser may require less suturing and faster visual rehabilitation."
IntraLase is developing commercially available software for these new applications as well as a new curved applanation lens to facilitate deep corneal dissections. The laser's current flat applanation lens provides the thin, planar flaps that have recently been shown to improve LASIK outcomes.


Intralase is a much safer and precise method of creating a corneal flap in the first step of Lasik. It accounts for approximately 18% of all first steps of today's Lasik procedures and is rapidly growing every day.
If you already have had Lasik done please let us know here what method was used to create your corneal flap. For instance was the Intralase Laser used (intra-lasik) , micro-keratome, hansetome, Amadeus or the LaFaci method? What was your experience like and how is the outcome of your Lasik procedure?

Nidek Laser Technolas Laser Ladar Laser Allegretto Laser Intralase Laser Hyperion Laser NearVision CK Visx Laser Mel 80 Laser Esiris Laser Laser Scan LSX Phasik
Lasik Links