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 for the software modifications for light delivery device (ldd) system: (1) update to allow patient data to be entered and saved prior to treatment session; (2) update to treatment summary report format to include 2d barcode, in addition to text file; (3) update gui (graphical user interface) display; and (4) update to the self-test routine to include additional confirmation of power reading prior to treatment.
| Device | RxSight Light Adjustable Lens and Light Delivery |
| Generic Name | Light Adjustable Lens (lal) And Light Delivery Device (ldd) |
| Applicant | RxSight, Inc. |
| Date Received | 2020-02-27 |
| Decision Date | 2020-05-21 |
| PMA | P160055 |
| Supplement | S011 |
| Product Code | PZK |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |