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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.
 
DeviceTECHNOLAS EXCIMER LASER SYSTEM (217A AND 217Z)
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
TECHNOLAS PERFECT VISION GMBH
messerschmittstr 1 + 3
munchen 80992
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004 S005 S006 S007 S009 S010 
S011 S012 S013 S015 S016 S017 S018 S019 S020 
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