BAUSCH& LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM
FDA premarket approval P990027/S009 · decided 2008-02-01
Approval details
- PMA number
- P990027
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BAUSCH& LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Technolas Perfect Vision GmbH
- Date received
- 2006-12-19
- Decision date
- 2008-02-01
- Days to decision
- 409 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- München
- Statement
- APPROVAL FOR THE EXPANSION OF THE PHYSICIAN ADJUSTMENT RANGE FOR THE SPHERICAL COMPONENT ROM +2.5 D TO -1.0 D.
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510(k) clearances by this applicant
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|---|---|---|
| VICTUS Femtosecond Laser Platform (K200724) | Technolas Perfect Vision GmbH | 2020-09-01 |
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| VICTUS FEMTOSECOND LASER PLATFORM (K141379) | Technolas Perfect Vision GmbH | 2015-01-16 |
| VICTUS FEMTOSECOND LASER PLATFORM (K140615) | Technolas Perfect Vision GmbH | 2014-07-15 |
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| VICTUS FEMTOSECOND LASER PLATFORM (K122386) | Technolas Perfect Vision GmbH | 2013-02-08 |
| VICTUS LASER PLATFORM (K120426) | Technolas Perfect Vision GmbH | 2012-07-31 |