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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 NameTECHNOLAS PERFECT VISION 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION
Classification Nameexcimer laser system
Generic Nameexcimer laser system
ApplicantTECHNOLAS GMBH PERFECT VISION
PMA NumberP990027
Supplement NumberS015
Date Received06/29/2010
Decision Date11/30/2010
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the advanced nomogram software module as an upgrade to the existing software of the technolas perfect vision® 217z zyoptix system for personalized vision correction. The advanced nomogram resides on a separate computer with the zylink treatment calculation software, and it leaves all hardware components and the laser beam control software module unchanged. The technolas perfect vision 217z zyoptix system for personalized vision correction with advanced nomogram software module is indicated for wavefront-guided laser assisted in-situ keratomileusis (lasik): 1) for the reduction or elimination of myopia with sphere up to -7. 00 d and cylinder up to -3. 00 d and mrse <=7. 50 d at the spectacle plane; 2) in patients with documented evidence of a change in manifest refraction of less than or equal to +-0. 50 diopters (in both cylinder and sphere components) for at least one year prior to the date of the pre-operative examination; and 3) in patients 21 years of age or older.
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