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 to the final fit v1. 11 and v1. 12 custom ablation treatment planning software for nidek ec-5000 excimer laser system. The updated final fit software is v1. 13.
| Device | EC-5000 EXCIMER LASER SYSTEM |
| Classification Name | Excimer Laser System |
| Generic Name | Excimer Laser System |
| Applicant | NIDEK CO., LTD. |
| Date Received | 2017-03-13 |
| Decision Date | 2017-06-08 |
| PMA | P970053 |
| Supplement | S016 |
| Product Code | LZS |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | NIDEK CO., LTD. 34-14 Maehama, Hiroishi-cho gamagori, Aichi 443-0-0038 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P970053 | Original Filing | |
| S017 | 2017-07-17 | Normal 180 Day Track |
| S016 | 2017-03-13 | Real-time Process |
| S015 | 2014-10-03 | Normal 180 Day Track |
| S014 | 2014-08-18 | Real-time Process |
| S013 | 2014-02-11 | Normal 180 Day Track |
| S012 | 2012-09-25 | Normal 180 Day Track |
| S011 | 2007-03-30 | Panel Track |
| S010 | 2006-08-08 | Normal 180 Day Track |
| S009 | 2005-11-23 | Panel Track |
| S008 | 2004-04-19 | Real-time Process |
| S007 | 2002-05-23 | Normal 180 Day Track |
| S006 | 2001-03-15 | Normal 180 Day Track |
| S005 | 2001-01-30 | Normal 180 Day Track |
| S004 | ||
| S003 | 2000-04-28 | Normal 180 Day Track |
| S002 | 1999-04-19 | Panel Track |
| S001 | 1999-02-16 | Panel Track |