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.
Expansion of the manufacturing to an additional building under the same fda establishment registration, addition of a large humidity chamber, and a modification to the optic surface molds
| Device | RxSight Light Adjustable Lens (LAL) and light Delivery (LDD) |
| 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 | 2019-03-06 |
| Decision Date | 2019-04-05 |
| PMA | P160055 |
| Supplement | S004 |
| Product Code | PZK |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |