Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: TECHNOLAS EXCIMER LASER SYSTEM (217A AND 217Z)
• Classification Name: excimer laser system
• Generic Name: excimer laser system
• Applicant: TECHNOLAS PERFECT VISION GMBH; messerschmittstr 1 + 3; munchen 80992
• PMA Number: P990027
• Date Received: 05/28/1999
• Decision Date: 02/23/2000
• 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