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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 NameBAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION
Classification Nameexcimer laser system
Generic Nameexcimer laser system
ApplicantBAUSCH & LOMB SURGICAL, INC.
PMA NumberP990027
Supplement NumberS006
Date Received07/18/2002
Decision Date10/10/2003
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 03M-0533
Notice Date 11/24/2003
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the bausch & lomb technolas 217z zyoptix system for personalized vision correction. The device uses an optical zone size between 6. 0 mm and 7. 0 mm with a constant blend zone of. 875 mm, and 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.
Approval Order Approval Order
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