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 changes in the spherical aberration and thickness of the optic lens for your isert® iols. You also requested approval for this lens to be distributed under a new private label under bausch + lomb inc. As the clariserttm preloaded iol system (model clsrt).
| Device | CLARISERT PRELOADED IOL SYSTEM |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | HOYA SURGICAL OPTICS, INC. |
| Date Received | 2016-12-28 |
| Decision Date | 2017-03-31 |
| PMA | P080004 |
| Supplement | S016 |
| Product Code | HQL |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HOYA SURGICAL OPTICS, INC. 14768 Pipeline Avenue chino Hills, CA 91709 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P080004 | Original Filing | |
| S043 | 2021-10-04 | Real-time Process |
| S042 | ||
| S041 | 2021-05-17 | 30-day Notice |
| S040 | 2021-04-12 | 30-day Notice |
| S039 | 2020-12-14 | 30-day Notice |
| S038 | 2020-12-14 | 30-day Notice |
| S037 | 2020-09-14 | 30-day Notice |
| S036 | ||
| S035 | ||
| S034 | 2020-03-18 | Real-time Process |
| S033 | ||
| S032 | 2020-02-12 | 30-day Notice |
| S031 | ||
| S030 | ||
| S029 | 2019-12-04 | 30-day Notice |
| S028 | ||
| S027 | 2019-11-01 | 30-day Notice |
| S026 | 2019-11-01 | 30-day Notice |
| S025 | 2019-09-04 | Real-time Process |
| S024 | 2019-07-23 | 30-day Notice |
| S023 | ||
| S022 | 2018-03-26 | 30-day Notice |
| S021 | 2018-01-05 | 30-day Notice |
| S020 | 2017-11-20 | 30-day Notice |
| S019 | 2017-11-08 | 135 Review Track For 30-day Notice |
| S018 | 2017-10-02 | 30-day Notice |
| S017 | 2017-04-10 | 135 Review Track For 30-day Notice |
| S016 | 2016-12-28 | Real-time Process |
| S015 | 2014-03-19 | Real-time Process |
| S014 | 2013-08-30 | 30-day Notice |
| S013 | 2012-12-19 | Real-time Process |
| S012 | 2012-05-29 | Real-time Process |
| S011 | 2012-05-18 | Normal 180 Day Track |
| S010 | 2011-12-23 | 30-day Notice |
| S009 | 2011-09-29 | 30-day Notice |
| S008 | 2011-07-18 | 135 Review Track For 30-day Notice |
| S007 | 2011-04-27 | Real-time Process |
| S006 | 2011-03-08 | 30-day Notice |
| S005 | 2010-02-23 | 135 Review Track For 30-day Notice |
| S004 | 2010-01-21 | Normal 180 Day Track |
| S003 | ||
| S002 | 2009-02-24 | 135 Review Track For 30-day Notice |
| S001 | 2009-01-14 | Normal 180 Day Track |