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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 NameALLEGRETTO WAVE EYE-Q LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser system
ApplicantWAVELIGHT LASER TECHNOLOGIE AG
PMA NumberP020050
Supplement NumberS003
Date Received04/06/2005
Decision Date06/16/2006
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
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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