PMA P990027S013
- Device
- TECHNOLAS 217A EXCIMER LASER SYSTEM
- Applicant
- Technolas Perfect Vision GmbH
- PMA number
- P990027
- Supplement
- S013
- Product code
- LZS
- Decision date
- 2009-11-04
- Classification
- Excimer Laser System
- Generic name
- Excimer laser system
- Approval order statement
- APPROVAL FOR SOFTWARE CHANGES INTRODUCED IN SOFTWARE VERSION 4.23A THAT AFFECTED THE ERROR MESSAGE DISPLAYS DURING THE CONDITIONING, ENERGY VERIFICATION, ANDTREATMENT PHASES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMETECHNOLAS T217Z ZYOPTIX LASER SYSTEM FOR PERSONALIZED VISION CORRECTION AND IS INDICATED FOR WAVEFRONT-GUIDED LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS FOR THE REDUCTIONOR ELIMINATION OF MYOPIA WITH SPHERE UP TO -7.00D AND CYLINDER UP TO -3.00D AND MRSE <=7.50D AT THE SPECTACLE PLANE.
Current openFDA PMA Record#
- Device
- TECHNOLAS 217A EXCIMER LASER SYSTEM
- Applicant
- Technolas Perfect Vision GmbH
- PMA number
- P990027
- Supplement
- S013
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2009-11-04
- Decision code
- APPR
- Date received
- 2009-10-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR SOFTWARE CHANGES INTRODUCED IN SOFTWARE VERSION 4.23A THAT AFFECTED THE ERROR MESSAGE DISPLAYS DURING THE CONDITIONING, ENERGY VERIFICATION, ANDTREATMENT PHASES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMETECHNOLAS T217Z ZYOPTIX LASER SYSTEM FOR PERSONALIZED VISION CORRECTION AND IS INDICATED FOR WAVEFRONT-GUIDED LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS FOR THE REDUCTIONOR ELIMINATION OF MYOPIA WITH SPHERE UP TO -7.00D AND CYLINDER UP TO -3.00D AND MRSE