PMA P990027S023
- Device
- TENEO 317 Model 2
- Applicant
- Technolas Perfect Vision GmbH
- PMA number
- P990027
- Supplement
- S023
- Product code
- LZS
- Decision date
- 2025-02-04
- Classification
- Ophthalmic
- Generic name
- Excimer laser system
- Approval order statement
- Approval for revision of the maximum gas fine filling time in the firmware for the Laser Head
Current openFDA PMA Record#
- Device
- TENEO 317 Model 2
- Applicant
- Technolas Perfect Vision GmbH
- PMA number
- P990027
- Supplement
- S023
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2025-02-04
- Decision code
- APPR
- Date received
- 2024-09-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for revision of the maximum gas fine filling time in the firmware for the Laser Head