BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION
FDA premarket approval P990027/S007 · decided 2006-03-15
Approval details
- PMA number
- P990027
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Trade name
- BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION
- Generic name
- Excimer laser system
- Applicant
- Technolas Perfect Vision GmbH
- Date received
- 2004-09-10
- Decision date
- 2006-03-15
- Days to decision
- 551 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- München
- 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.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VICTUS Femtosecond Laser Platform (K200724) | Technolas Perfect Vision GmbH | 2020-09-01 |
| VICTUS Femtosecond Laser Platform (K171014) | Technolas Perfect Vision GmbH | 2017-10-19 |
| VICTUS Femtosecond Laser Platform (K151161) | Technolas Perfect Vision GmbH | 2015-06-24 |
| VICTUS FEMTOSECOND LASER PLATFORM (K141379) | Technolas Perfect Vision GmbH | 2015-01-16 |
| VICTUS FEMTOSECOND LASER PLATFORM (K140615) | Technolas Perfect Vision GmbH | 2014-07-15 |
| VICTUS FEMTOSECOND LASER PLATFORM (K132534) | Technolas Perfect Vision GmbH | 2014-02-14 |
| VICTUS FEMTOSECOND LASER PLATFORM (K122386) | Technolas Perfect Vision GmbH | 2013-02-08 |
| VICTUS LASER PLATFORM (K120426) | Technolas Perfect Vision GmbH | 2012-07-31 |