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 post-approval study protocol, “rxsight light adjustable lens (lal) and light delivery device (ldd) new enrollment study,” and modifications to the lal posterior layer, the lal haptic attachment manufacturing process, and the ldd light source, table configuration, infrared anterior segment illumination, and contact lens.
| Device | RxSight Light Adjustable Lens (LAL) and Light Delivery |
| Classification Name | Light Adjustable Lens (lal) And Light Delivery Device (ldd) |
| Generic Name | Light Adjustable Lens (lal) And Light Delivery Device (ldd) |
| Applicant | RxSight, Inc. |
| Date Received | 2018-09-05 |
| Decision Date | 2019-03-04 |
| PMA | P160055 |
| Supplement | S002 |
| Product Code | PZK |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| 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 |