Exposing the LASIK Scam

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 Post subject: WaveLight ALLEGRETTO WAVE receives approval for upgrade
PostPosted: Tue Jul 25, 2006 12:44 pm 
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http://www.fda.gov/cdrh/pma/pmajun06.html

P020050/S003
6/16/06

180-Day WaveLight ALLEGRETTO WAVE EYE-Q Excimer Laser System SurgiVision? Regulatory Consultants, LLC
North Reading , MA 01864

Approval for a change in repetition rate from 200 Hz to 400 Hz. The device, as modified, will be marketed under the trade name ALLEGRETTO WAVE EYE-Q Excimer Laser System and is indicated for laser assisted in situ keratomileusis (LASIK) in patients who are 18 years of age or older: 1) for the reduction or elimination of myopia of up to -12.0 diopters (D) of sphere and up to -6.0 D of astigmatism at the spectacle plane in patients with documentation of a stable manifest refraction defined as ≤0.50 D of preoperative spherical equivalent shift over one year prior to surgery; and 2) for the reduction or elimination of hyperopic refractive errors up to +6.0 D of sphere with and without astigmatic refractive errors up to 5.0 D at the spectacle plane, with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D in patients with documentation of a stable manifest refraction defined as ≤0.50 D of preoperative spherical equivalent shift over one year prior to surgery, exclusive of changes due to unmasking latent hyperopia.

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 Post subject:
PostPosted: Tue Jul 25, 2006 12:47 pm 
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http://www.osnsupersite.com/view.asp?rID=17693

OSN SuperSite Top Story 7/17/2006

WaveLight receives FDA approval for latest wavefront-optimized laser system

STERLING, Va. ? The Food and Drug Administration had granted U.S. marketing approval to WaveLight Inc. for its latest-generation wavefront-optimized excimer laser system, the company announced in a press release.

The approval covers the 400 Hz Allegretto Wave Eye-Q excimer laser for use in LASIK to correct myopia up to ?12 D with up to ?6 D of astigmatism, as well as for hyperopic corrections up to 6 D with up to 5 D of astigmatism, according to the release.

The FDA based the approval for myopic indications on data from U.S. clinical trials involving 901 eyes. At 3 months, stability analysis for 844 eligible eyes showed 98% achieved an uncorrected visual acuity (UCVA) of 20/40 or better, and 84.4% achieved 20/20 or better.

The hyperopia treatment indications were based on data for 290 eyes. At 6 months, stability analysis for 212 eligible eyes showed 95.3% achieved an UCVA of 20/40 or better, and 67.5% achieved 20/20 or better.

The 400 Hz repetition rate allows the Allegretto Wave Eye-Q to deliver 1 D of correction in 2 seconds with a 6.5-mm optical zone, according to the release. The reduced treatment time allows for shorter, more comfortable procedures and may be particularly beneficial for treating high myopia, high astigmatism or other time-intensive procedures, company officials noted.

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 Post subject:
PostPosted: Fri Aug 18, 2006 1:15 pm 
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http://www.fda.gov/cdrh/pdf2/p020050s004.html

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PostPosted: Sat Aug 19, 2006 2:48 am 
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An improvement in lasik technology with all the risks and damage still there. Very high prescriptions are at increased risk and experience worse vision, more aberrations

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Lasik damages every eye! Lasik induces more aberrations, even so called "wavefront!" Stick to glasses!


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 Post subject:
PostPosted: Sun Oct 22, 2006 7:53 pm 
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Faster frequencies mean less exposure to damaging radiation, which means less dry eye. But you won't see that in any official documents.


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