PMA P930016S058

Device
iDESIGN Refractive Studio
Applicant
Amo Manufacturing USA, LLC
PMA number
P930016
Supplement
S058
Product code
LZS
Decision date
2019-05-03
Classification
Excimer Laser System
Generic name
Excimer laser system
Approval order statement
Approval for a custom-designed replacement micro display driver in your iDESIGN Refractive Studio.

Current openFDA PMA Record#

Device
iDESIGN Refractive Studio
Applicant
Amo Manufacturing USA, LLC
PMA number
P930016
Supplement
S058
Product code
LZS
Generic name
Excimer laser system
Decision date
2019-05-03
Decision code
APPR
Date received
2019-01-22
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a custom-designed replacement micro display driver in your iDESIGN Refractive Studio.