PMA P150040S001

Device
VISUMAX FEMTOSECOND LASER SYSTEM
Applicant
Carl Zeiss Meditec, Inc.
PMA number
P150040
Supplement
S001
Product code
OTL
Decision date
2017-02-28
Classification
Femtosecond Laser System For Refractive Correction
Generic name
Femtosecond laser system for refractive correction
Approval order statement
Approval for software changes.

Current openFDA PMA Record#

Device
VISUMAX FEMTOSECOND LASER SYSTEM
Applicant
Carl Zeiss Meditec, Inc.
PMA number
P150040
Supplement
S001
Product code
OTL
Generic name
Femtosecond laser system for refractive correction
Decision date
2017-02-28
Decision code
APPR
Date received
2017-01-06
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for software changes.