MEDITEC MEL 80 EXCIMER LASER SYSTEM
FDA premarket approval P060004/S001 · decided 2011-03-28
Approval details
- PMA number
- P060004
- Supplement
- S001
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDITEC MEL 80 EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Carl Zeiss Meditec, Inc.
- Date received
- 2007-12-28
- Decision date
- 2011-03-28
- Days to decision
- 1186 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. THIS DEVICE USES AN OPTICAL ZONE OF 6.0 TO 6.5 MM IN DIAMETER AND A TRANSITION ZONE OF 2.0 TO 4.0 MM FOR A TOTAL ABLATION DIAMETER OF 10.0 MM, AND IS INDICATED FOR PRIMARY LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) TREATMENTS FOR: 1) THE REDUCTION OR ELIMINATION OF NATURALLY-OCCURRING HYPEROPIA OF LESS THAN OR EQUAL TO +5.0 D WITH OR WITHOUT REFRACTIVE ASTIGMATISM OF > +0.5 AND <= +3.0D, WITH A MAXIMUM MRSE OF +5.0D; 2) IN PATIENTS WHO ARE 21 YEAR
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510(k) clearances by this applicant
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|---|---|---|
| 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 |