PMA P060004
- Device
- MEL 90 Excimer Laser
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P060004
- Supplement
- S001
- Product code
- LZS
- Decision date
- 2026-07-01
- Generic name
- Excimer laser system
- Approval order statement
- new replacement infrared (IR) light-emitting diodes (LEDs) with subsequent changes to the IR LED Power Supply Printed Circuit Board Assembly (PCBA)
- 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
- S010
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2026-07-01
- Decision code
- APPR
- Date received
- 2026-04-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- new replacement infrared (IR) light-emitting diodes (LEDs) with subsequent changes to the IR LED Power Supply Printed Circuit Board Assembly (PCBA)