PMA P150040S018

Device: VisuMax Femtosecond Laser
Applicant: Carl Zeiss Meditec, Inc.
PMA number: P150040
Supplement: S018
Product code: OTL
Decision date: 2024-10-16
Classification: Ophthalmic
Generic name: Femtosecond laser system for refractive correction
Approval order statement: the replacement of the last two lead-containing lenses (F2 glass material) in the Scanoptics Complete Module of the VisuMax Femtosecond Laser with optional lead-free lenses (N-F2 glass material).

Current openFDA PMA Record#

Device: VisuMax Femtosecond Laser
Applicant: Carl Zeiss Meditec, Inc.
PMA number: P150040
Supplement: S018
Product code: OTL
Generic name: Femtosecond laser system for refractive correction
Decision date: 2024-10-16
Decision code: APPR
Date received: 2024-07-24
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: the replacement of the last two lead-containing lenses (F2 glass material) in the Scanoptics Complete Module of the VisuMax Femtosecond Laser with optional lead-free lenses (N-F2 glass material).