PMA P990027S025

Device
TENEO 317 Model 2
Applicant
Technolas Perfect Vision GmbH
PMA number
P990027
Supplement
S025
Product code
LZS
Decision date
2025-02-06
Classification
Ophthalmic
Generic name
Excimer laser system
Approval order statement
Approval for a pipeline optimization for the Argon Fluoride gas supply and revision to the Nitrogen gas supply.

Current openFDA PMA Record#

Device
TENEO 317 Model 2
Applicant
Technolas Perfect Vision GmbH
PMA number
P990027
Supplement
S025
Product code
LZS
Generic name
Excimer laser system
Decision date
2025-02-06
Decision code
APPR
Date received
2024-11-06
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a pipeline optimization for the Argon Fluoride gas supply and revision to the Nitrogen gas supply.