PMA P060004S009
- Device
- MEL 90 EXCIMER LASER SYSTEM
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P060004
- Supplement
- S009
- Product code
- LZS
- Decision date
- 2025-05-23
- Classification
- Ophthalmic
- Generic name
- Excimer laser system
- Approval order statement
- new replacement infrared (IR) light-emitting diodes (LEDs) with subsequent changes to the IR LED Supply Printed Circuit Board Assembly and the IR LED assembly
Current openFDA PMA Record#
- Device
- MEL 90 EXCIMER LASER SYSTEM
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P060004
- Supplement
- S009
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2025-05-23
- Decision code
- APPR
- Date received
- 2025-02-26
- 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 Supply Printed Circuit Board Assembly and the IR LED assembly