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 LASER SYSTEM
• Generic Name: Excimer laser system
• Applicant: TECHNOLAS PERFECT VISION GMBH; MESSERSCHMITTSTR 1 + 3; MUNCHEN 80992
• PMA Number: P990027
• Supplement Number: S011
• Date Received: 09/03/2008
• Decision Date: 05/01/2009
• Product Code: LZS
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
APPROVAL FOR THE DYNAMIC ROTATIONAL EYE TRACKER WITH IRIS RECOGNITION FOR USE WITH THE BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX LASER SYSTEM FOR PERSONALIZED VISIONCORRECTION. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TECHNOLAS 217Z ZYOPTIX LASER SYSTEM FOR PERSONALIZED VISION CORRECTION AND IS INDICATED FOR:1) WAVEFRONT-GUIDED LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS FOR THE REDUCTION ORELIMINATION OF MYOPIA WITH SPHERE UP TO -7.00 D AND CYLINDER UP TO -3.00 D AND MRSE < = 7.50 D ATTHE SPECTACLE PLANE:REDUCTION OR ELIMINATION OF MYOPIA (NEARSIGHTEDNESS) FROM -1.00 D TO -7.00 D WITH LESS THAN -3.00 D ASTIGMATISM;2) 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; AND 4) REDUCTION OR ELIMINATION OF LOW-TO-MODERATE NATURALLY OCCURRING HYPEROPIA UP TO +4.00 D MRSE, WITH SPHERE BETWEEN +1.00 D TO +4.00 D WITH OR WITHOUT REFRACTIVE ASTIGMATISM UP TO+2.00 D AT THE SPECTACLE PLANE.