MEL 80 Excimer Laser System
FDA premarket approval P060004/S004 · decided 2023-02-16
Approval details
- PMA number
- P060004
- Supplement
- S004
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEL 80 Excimer Laser System
- Generic name
- Excimer laser system
- Applicant
- Carl Zeiss Meditec, Inc.
- Date received
- 2023-01-23
- Decision date
- 2023-02-16
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Dublin, CA
- Statement
- Change the coating of the d24 VIS Window component of the laser.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CLARUS (700) (K243878) | Carl Zeiss Meditec, Inc. | 2025-04-17 |
| CIRRUS™ HD-OCT Model 6000 (K233933) | Carl Zeiss Meditec, Inc. | 2024-05-17 |
| VISULAS yag (K230350) | Carl Zeiss Meditec, Inc. | 2023-09-22 |
| Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) (K231075) | Carl Zeiss Meditec, Inc. | 2023-06-20 |
| CIRRUS HD-OCT (K222200) | Carl Zeiss Meditec, Inc. | 2023-04-13 |
| CLARUS (K191194) | Carl Zeiss Meditec, Inc. | 2019-06-25 |
| CIRRUS HD-OCT (K181534) | Carl Zeiss Meditec, Inc. | 2019-02-15 |
| CLARUS (K181444) | Carl Zeiss Meditec, Inc. | 2019-01-10 |