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: BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION
• Generic Name: Excimer laser system
• Applicant: Technolas Perfect Vision GmbH; Messerschmittstr. 1+ 3; München 80992
• PMA Number: P990027
• Supplement Number: S006
• Date Received: 07/18/2002
• Decision Date: 10/10/2003
• Product Code: LZS
• Docket Number: 03M-0533
• Notice Date: 11/24/2003
• Advisory Committee: Ophthalmic
• Supplement Type: Panel Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

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