PMA P150040S004
- Device
- VisuMax Femtosecond Laser
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P150040
- Supplement
- S004
- Product code
- OTL
- Decision date
- 2019-07-25
- Classification
- Femtosecond Laser System For Refractive Correction
- Generic name
- Femtosecond laser system for refractive correction
- Approval order statement
- Approval of the 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
- S004
- Product code
- OTL
- Generic name
- Femtosecond laser system for refractive correction
- Decision date
- 2019-07-25
- Decision code
- APPR
- Date received
- 2018-12-11
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.