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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 EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameophthalmic medical laser system (193 nanometer wavelength)
ApplicantWAVELIGHT AG
PMA NumberP030008
Supplement NumberS004
Date Received10/24/2005
Decision Date04/19/2006
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 06M-0199
Notice Date 05/12/2006
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the wavelight allegretto wave excimer laser system. The device used optical zones of 6. 0-7. 0 mm with an ablation/treatment zone up to 9. 0 mm, 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; 2) patients who are 21 years of age or older; and 3) patients with documentation of a stable manifest refraction defined as <= 0. 50 d preoperative spherical equivalent shift over one year prior to surgery.
Approval Order Approval Order
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