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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameWAVELIGHT ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser system
ApplicantALCON LABORATORIES, INC.
PMA NumberP020050
Supplement NumberS005
Date Received12/19/2006
Decision Date04/09/2007
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the 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) for: 1) the reduction or elimination of naturally occurring mixed astigmatism of up to 6. 00 diopters (d) at the spectacle plane in patients who are 21 years of age or older 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) the wavefront-guided (wfg) reduction or elimination of up to -7. 00 diopters (d) of spherical equivalent myopia or myopia with astigmatism, with up to -7. 00 d of spherical component and up to 3. 00 d of astigmatic component at the spectacle plane in patients who are 18 years of age or older with documentation of a stable manifest refraction defined as <=0. 50 d of preoperative spherical shift over one year prior to surgery.
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