PMA P990027S024

Device
TENEO 317 Model 2
Applicant
Technolas Perfect Vision GmbH
PMA number
P990027
Supplement
S024
Product code
LZS
Decision date
2024-12-16
Classification
Ophthalmic
Generic name
Excimer laser system
Approval order statement
Approval for an alternate resistor in the electrical unit of the Technolas Excimer Laser System (217a and 217z).

Current openFDA PMA Record#

Device
TENEO 317 Model 2
Applicant
Technolas Perfect Vision GmbH
PMA number
P990027
Supplement
S024
Product code
LZS
Generic name
Excimer laser system
Decision date
2024-12-16
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 an alternate resistor in the electrical unit of the Technolas Excimer Laser System (217a and 217z).