Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: TECHNOLAS 217A EXCIMER LASER SYSTEM
• Generic Name: Excimer laser system
• Applicant: TECHNOLAS PERFECT VISION GMBH; MESSERSCHMITTSTR 1 + 3; MUNCHEN 80992
• PMA Number: P990027
• Supplement Number: S002
• Date Received: 11/24/2000
• Decision Date: 05/17/2002
• Product Code: LZS
• Docket Number: 02M-0299
• Notice Date: 07/02/2002
• Advisory Committee: Ophthalmic
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
APPROVAL THE TECHNOLAS 217A EXCIMER LASER SYSTEM. THIS DEVICE IS INDICATED FOR LASER IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS: 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIC ASTIGMATISM UP TO -12.00 D MRSE, WITH SPHERE BETWEEN >-7.00 D TO -10.99 D AND CYLINDER BETWEEN 0.00 AND <-3.00 D; 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 WHO ARE 21 YEARS OF AGE OR OLDER.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2