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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.
Classification Nameexcimer laser system
Generic Nameophthalmic medical laser system (193 nanometer wavelength)
PMA NumberP030008
Supplement NumberS017
Date Received02/02/2015
Decision Date05/01/2015
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 to expand the approval of the topolyzer vario to include its use as a diagnostic device supporting the wavelight excimer lasers in performing t-cat lasik. The device, as modified, will be marketed under the trade name allegro topolyzer vario and is indicated for the wavelight allegretto wave® eye-q excimer laser system used in conjunction with the wavelight allegro topolyzer (topographer) or allegro topolyzer vario (topographer) and t-cat treatment planning software is indicated for performing topography-guided laser assisted in situ keratomileusis (topo-guided (t-cat) lasik): 1) for the reduction or elimination of up to -9. 00 diopters (d) of spherical equivalent myopia or myopia with astigmatism, with up to -8. 00 d of spherical component and up to -3. 00 d of astigmatic component at the spectacle plane; 2) in patients who are 18 years of age or older; and 3) in patients with documentation of a stable manifest refraction defined as 0. 50 d or less of preoperative spherical equivalent shift over one year prior to surgery.