The introduction of an alternate tyvek package heat sealer to meet increased manufacturing capacity
Device | Light Adjustable Lens (LAL) and Light Delivery (LDD) |
Generic Name | Light Adjustable Lens (lal) And Light Delivery Device (ldd) |
Applicant | RxSight, Inc. |
Date Received | 2021-03-04 |
Decision Date | 2021-04-01 |
PMA | P160055 |
Supplement | S019 |
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 |
Supplemental Filings
Supplement Number | Date | Supplement Type |
P160055 | | Original Filing |
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 | | |
NIH GUDID Devices