This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
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 >= -1. 00 d to
| 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 | 2015-10-30 |
| Decision Date | 2016-09-13 |
| Notice Date | 2016-09-16 |
| PMA | P150040 |
| Supplement | S |
| Product Code | OTL |
| Docket Number | 16M-2735 |
| Advisory Committee | Ophthalmic |
| 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 |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 04049471100136 | P150040 | 012 |
| 04049471100167 | P150040 | 012 |
| 04049471100150 | P150040 | 012 |
| 04049471100143 | P150040 | 012 |
| 04049471095111 | P150040 | 012 |