This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the nidek ec-5000 excimer laser system. This device is indicated for photorefractive keratectomy (prk) for the reduction or elimination of mild to moderate myopia in patients with the following three characterisitics: 1) in prk treatments for the reduction or elimination of myopia in the low, moderate, or high ranges (-0. 75 diopters (d) to -13. 00d) spherical equivalent (s. E. ) at the spectacle plan, uncomplicated by refractive astigmatism (i. E. ,
| Device | EC-5000 EXCIMER LASER SYSTEM |
| Classification Name | Excimer Laser System |
| Generic Name | Excimer Laser System |
| Applicant | NIDEK CO., LTD. |
| Date Received | 1997-11-06 |
| Decision Date | 1998-12-17 |
| Notice Date | 2000-12-08 |
| PMA | P970053 |
| Supplement | S |
| Product Code | LZS |
| Docket Number | 00M-1640 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | NIDEK CO., LTD. 34-14 Maehama, Hiroishi-cho gamagori, Aichi 443-0-0038 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| 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 |