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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameTECHNOLAS EXCIMER LASER SYSTEM (217A AND 217Z)
Classification Nameexcimer laser system
Generic Nameexcimer laser
ApplicantTECHNOLAS PERFECT VISION GMBH
PMA NumberP990027
Date Received05/28/1999
Decision Date02/23/2000
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 00M-1597
Notice Date 11/03/2000
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the technolas(r) 217a excimer laser system. The devices is indicated to perform laser in-situ keratomileusis (lasik): 1) in treatments for the reduction or eliminatino of myopia (nearsightedness) from -1. 00 to -7. 00 diopters d with less than -3. 00 d astigmatism; 2) in patients with documented stability of refraction for the prior 12 months as demonstrated by a change in manifest refraction of less than or equal to 0. 5 d (in both cylinder and sphere components); and, 3) in patients 21 years of age or older.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S009 S010 
S011 S012 S013 S015 S016 S017 S018 S019 
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