PMA P990027S007
- Device
- BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION
- Applicant
- Technolas Perfect Vision GmbH
- PMA number
- P990027
- Supplement
- S007
- Product code
- LZS
- Decision date
- 2006-03-15
- Classification
- Excimer Laser System
- Generic name
- Excimer laser system
- Approval order statement
- APPROVAL FOR: 1) AN INCREASE IN THE LASER PULSE REPETITION FREQUENCY FROM THE CURRENT 50 HZ TO 100 HZ; 2)REPLACEMENT OF THE CERATUBE MIDI V.4.1 LASER WITH THE CERATUBE MIDI V.5.2 LASER; 3) SOFTWARE REVISIONS TO ACCOMMODATE THE NEW LASER AND PULSE RATE; 4) LABELING CHANGES TO DOCUMENT THESE MODIFICATIONS.
Current openFDA PMA Record#
- Device
- BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION
- Applicant
- Technolas Perfect Vision GmbH
- PMA number
- P990027
- Supplement
- S007
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2006-03-15
- Decision code
- APPR
- Date received
- 2004-09-10
- Supplement type
- Normal 180 Day Track
- Approval order statement
- APPROVAL FOR: 1) AN INCREASE IN THE LASER PULSE REPETITION FREQUENCY FROM THE CURRENT 50 HZ TO 100 HZ; 2)REPLACEMENT OF THE CERATUBE MIDI V.4.1 LASER WITH THE CERATUBE MIDI V.5.2 LASER; 3) SOFTWARE REVISIONS TO ACCOMMODATE THE NEW LASER AND PULSE RATE; 4) LABELING CHANGES TO DOCUMENT THESE MODIFICATIONS.