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.
| Device | VisuMax Femtosecond Laser |
| Generic Name | Femtosecond Laser System For Refractive Correction |
| Applicant | Carl Zeiss Meditec, Inc.5160 Hacienda Drivedublin, CA 94568 PMA NumberP150040 Supplement NumberS011 Date Received11/22/2022 Decision Date12/21/2022 Product Code OTL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-11-22 |
| Decision Date | 2022-12-21 |
| PMA | P150040 |
| Supplement | S011 |
| Product Code | OTL |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Carl Zeiss Meditec, Inc. 5160 Hacienda Drive dublin, CA 94568 PMA NumberP150040 Supplement NumberS011 Date Received11/22/2022 Decision Date12/21/2022 Product Code OTL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement to Qualify An Additional Manufacturing Site For The Supplier Of The Contact Glass Used In The Treatment Pack Accessory |
| 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 |