TENEO 317 Model 2
FDA premarket approval P990027/S025 · decided 2025-02-06
Approval details
- PMA number
- P990027
- Supplement
- S025
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TENEO 317 Model 2
- Generic name
- Excimer laser system
- Applicant
- Technolas Perfect Vision GmbH
- Date received
- 2024-11-06
- Decision date
- 2025-02-06
- Days to decision
- 92 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- München
- Statement
- Approval for a pipeline optimization for the Argon Fluoride gas supply and revision to the Nitrogen gas supply.
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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 |