PMA P150040S013
- Device
- VisuMax Femtosecond Laser
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P150040
- Supplement
- S013
- Product code
- OTL
- Decision date
- 2023-04-13
- Classification
- Ophthalmic
- Generic name
- Femtosecond laser system for refractive correction
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- VisuMax Femtosecond Laser
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P150040
- Supplement
- S013
- Product code
- OTL
- Generic name
- Femtosecond laser system for refractive correction
- Decision date
- 2023-04-13
- Decision code
- APPR
- Date received
- 2023-03-14
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.