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 NumberS010 Date Received05/23/2022 Decision Date06/17/2022 Product Code OTL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-05-23 |
| Decision Date | 2022-06-17 |
| PMA | P150040 |
| Supplement | S010 |
| 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 NumberS010 Date Received05/23/2022 Decision Date06/17/2022 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 Replace The Type Of UV Light And The Supplier Of The UV Light Chamber For The Treatment Pack Accessory For The VisuMax Femtosecond Laser |
| 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 |