| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | MEL90 |
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| Generic Name | Excimer laser system |
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| Applicant | Carl Zeiss Meditec, Inc.
5160 Hacienda Drive
Dublin, CA 94568 |
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| PMA Number | P060004 |
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| Supplement Number | S006 |
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| Date Received | 08/21/2023 |
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| Decision Date | 12/04/2024 |
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| Product Code |
LZS |
| Docket Number | 24M-5643 |
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| Notice Date | 12/20/2024 |
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| Advisory Committee |
Ophthalmic |
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| Clinical Trials | NCT04082078
|
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| Supplement Type | Panel Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order 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 patients who are 18 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in MRSE within +/- 0.50 |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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