Approval for the visumax femtosecond laser. This device is indicated for use in small incision lenticule extraction (smile) for the reduction or elimination of myopia with or without astigmatism:1) for spherical refractive error (in minus cylinder format) from -1. 00 diopters through -10. 00 diopters;2) for cylinder from -0. 75 diopters through -3. 00 diopters; and3) when refraction spherical equivalent is no greater in magnitude than 10. 00 diopters, in patients 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in sphere and cylinder of less than or equal to 0. 50 d in magnitude.
| Device | VisuMax Femtosecond Laser |
| Classification Name | Femtosecond Laser System For Refractive Correction |
| Generic Name | Femtosecond Laser System For Refractive Correction |
| Applicant | Carl Zeiss Meditec, Inc. |
| Date Received | 2018-03-23 |
| Decision Date | 2018-10-04 |
| Notice Date | 2018-10-25 |
| PMA | P150040 |
| Supplement | S003 |
| Product Code | OTL |
| Docket Number | 18M-3842 |
| Advisory Committee | Ophthalmic |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Carl Zeiss Meditec, Inc. 5160 Hacienda Drive dublin, CA 94568 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
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