PMA P150040S020
- Device
- VisuMax; VISUMAX 800
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P150040
- Supplement
- S020
- Product code
- OTL
- Decision date
- 2025-12-18
- Classification
- Ophthalmic
- Generic name
- Femtosecond laser system for refractive correction
- Approval order statement
- labeling update that includes the Post-Approval study data from the VisuMax SMILE New Enrollment Study for the VisuMax Femtosecond Laser
Current openFDA PMA Record#
- Device
- VisuMax; VISUMAX 800
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P150040
- Supplement
- S020
- Product code
- OTL
- Generic name
- Femtosecond laser system for refractive correction
- Decision date
- 2025-12-18
- Decision code
- APPR
- Date received
- 2025-06-23
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- labeling update that includes the Post-Approval study data from the VisuMax SMILE New Enrollment Study for the VisuMax Femtosecond Laser