MEL 80 EXCIMER LASER SYSTEM
FDA premarket approval P060004 · decided 2006-08-11
Approval details
- PMA number
- P060004
- Trade name
- MEL 80 EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Carl Zeiss Meditec, Inc.
- Date received
- 2006-02-14
- Decision date
- 2006-08-11
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Dublin, CA
- Statement
- APPROVAL FOR THE MEL 80 EXCIMER LASER SYSTEM. THE DEVICE USES AN OPTICAL ZONE OF 6.0 TO 7.0 MM IN DIAMETER AND A TRANSITION ZONE OF 1.7 TO 1.9 MM FOR TOTAL ABLATION DIAMETER OF 7.7 TO 8.9 MM, AND IS INDICATED FOR PRIMARY LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) TREATMENTS FOR: 1) THE REDUCTION OR ELIMINATION OF MYOPIA OF LESS THAN OR EQUAL TO -7.0 D, WITH OR WITHOUT REFRACTIVE ASTIGMATISM OF LESS THAN OR EQUAL TO -3.0 D, WITH A MAXIMUM MRSE OF -7.00 D; 2) IN PATIENTS WHO ARE 21 YEARS OF AGE
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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 |