PMA P060004S007

Device
MEL 80 Excimer Laser
Applicant
Carl Zeiss Meditec, Inc.
PMA number
P060004
Supplement
S007
Product code
LZS
Decision date
2024-03-13
Classification
Ophthalmic
Generic name
Excimer laser system
Approval order statement
modification of the electrical motor in the vacuum pump sub-unit

Current openFDA PMA Record#

Device
MEL 80 Excimer Laser
Applicant
Carl Zeiss Meditec, Inc.
PMA number
P060004
Supplement
S007
Product code
LZS
Generic name
Excimer laser system
Decision date
2024-03-13
Decision code
APPR
Date received
2023-12-14
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
modification of the electrical motor in the vacuum pump sub-unit