PMA P060004
- Device
- MEL 90 Excimer Laser
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P060004
- Supplement
- S001
- Product code
- LZS
- Decision date
- 2026-04-30
- Generic name
- Excimer laser system
- Approval order statement
- updates to the quality inspection process for the Fluence Test Cards
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf6/P060004S001B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- MEL 90 Excimer Laser
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P060004
- Supplement
- S011
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2026-04-30
- Decision code
- OK30
- Date received
- 2026-04-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- updates to the quality inspection process for the Fluence Test Cards