Approval for the replacement of the fiber-optic laser source hardware module.
| Device | VisuMax Femtosecond Laser System |
| Classification Name | Femtosecond Laser System For Refractive Correction |
| Generic Name | Femtosecond Laser System For Refractive Correction |
| Applicant | Carl Zeiss Meditec, Inc. |
| Date Received | 2018-02-28 |
| Decision Date | 2018-05-02 |
| PMA | P150040 |
| Supplement | S002 |
| Product Code | OTL |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Carl Zeiss Meditec, Inc. 5160 Hacienda Drive dublin, CA 94568 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P150040 | | Original Filing |
| S011 |
2022-11-22 |
30-day Notice |
| S010 |
2022-05-23 |
30-day Notice |
| S009 |
2021-01-25 |
30-day Notice |
| S008 |
2020-11-19 |
Normal 180 Day Track |
| S007 |
2020-10-29 |
30-day Notice |
| S006 |
2020-09-08 |
30-day Notice |
| S005 |
2020-03-20 |
30-day Notice |
| S004 |
2018-12-11 |
Normal 180 Day Track No User Fee |
| S003 |
2018-03-23 |
Panel Track |
| S002 |
2018-02-28 |
Real-time Process |
| S001 |
2017-01-06 |
Real-time Process |
NIH GUDID Devices