MEL90
FDA premarket approval P060004/S006 · decided 2024-12-04
Approval details
- PMA number
- P060004
- Supplement
- S006
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEL90
- Generic name
- Excimer laser system
- Applicant
- Carl Zeiss Meditec, Inc.
- Date received
- 2023-08-21
- Decision date
- 2024-12-04
- Days to decision
- 471 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Dublin, CA
- Statement
- This device is indicated for use in primary Laser-Assisted in situ Keratomileusis (LASIK) treatments for the reduction or elimination of: Myopia less in magnitude than -10.00 D sphere (in minus-cylinder notation), with and without cylinder up to -4.00 D, when MRSE is less in magnitude than -10.00 D; Hyperopia up to +4.00 D sphere (in plus-cylinder notation), with and without cylinder up to +3.00 D, when MRSE is up to +5.00 D; and Mixed astigmatism with cylinder from >1.00 D up to 4.00 D;in pa
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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 |