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 a new 1 khz eyetracker, which replaces the original 200 hz eyetracker used with the ec-5000 excimer laser. This change also includes modification to the associated camera and software as well as the infrared red (ir) illumination. This device is indicated for topography-assisted laser- assisted in-situ keratomileusis (lasik) treatment using the final fit custom ablation treatment planning software for the reduction or elimination of myopic refractive errors from -1. 0 to - 4. 0 d of sphere with astigmatic refractive errors from >-0. 5 to -2. 0 d at the spectacle plane; in patients 21 years of age or older; and, in patients with documented stability of manifest refraction over the prior year, demonstrated by a change in mrse not greater than +=0. 5 d.
| Device | NIDEK EXCLAIMER LASER SYSTEM EC-5000 |
| Classification Name | Excimer Laser System |
| Generic Name | Excimer Laser System |
| Applicant | NIDEK CO., LTD. |
| Date Received | 2014-10-03 |
| Decision Date | 2015-03-30 |
| PMA | P970053 |
| Supplement | S015 |
| Product Code | LZS |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| 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 |