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.
Approval of the revised protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p160055
| Device | RxSight Light Adjustable Lens and Light Delivery |
| Generic Name | Light Adjustable Lens (lal) And Light Delivery Device (ldd) |
| Applicant | RxSight, Inc. |
| Date Received | 2020-01-30 |
| Decision Date | 2020-05-22 |
| PMA | P160055 |
| Supplement | S009 |
| Product Code | PZK |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | RxSight, Inc. 100 Columbia aliso Viejo, CA 92656 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160055 | Original Filing | |
| S026 | 2022-11-09 | 30-day Notice |
| S025 | ||
| S024 | ||
| S023 | 2022-06-09 | 30-day Notice |
| S022 | ||
| S021 | 2021-09-10 | Normal 180 Day Track No User Fee |
| S020 | ||
| S019 | 2021-03-04 | 30-day Notice |
| S018 | 2021-02-25 | 30-day Notice |
| S017 | 2021-02-08 | Normal 180 Day Track No User Fee |
| S016 | 2020-11-27 | Real-time Process |
| S015 | ||
| S014 | ||
| S013 | ||
| S012 | ||
| S011 | 2020-02-27 | Real-time Process |
| S010 | ||
| S009 | 2020-01-30 | Normal 180 Day Track No User Fee |
| S008 | 2019-09-13 | Real-time Process |
| S007 | 2019-08-19 | 30-day Notice |
| S006 | 2019-05-23 | 30-day Notice |
| S005 | ||
| S004 | 2019-03-06 | 30-day Notice |
| S003 | 2018-11-07 | Normal 180 Day Track No User Fee |
| S002 | 2018-09-05 | Normal 180 Day Track |
| S001 |