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 to modify the approved claim for the ec-5000 excimer laser system to allow for threatments using an optical zone size of 5. 5 mm to 6. 5 mm, in addition to the approved optical zone size of t. T mm, for lasik treatment of myopia and myopia with astigmatism. The device, as modified, will continue to be marketed under the trade name nidek ec-5000 excimer laser system and remains indicated for the reduction or elimination of -1. 00 d to -14. 00 d myopia spherical equivalent with or without
| Device | NIDEK EC-5000 EXCIMER LASER SYSTEM |
| Classification Name | Excimer Laser System |
| Generic Name | Excimer Laser System |
| Applicant | NIDEK CO., LTD. |
| Date Received | 2001-03-15 |
| Decision Date | 2001-09-04 |
| PMA | P970053 |
| Supplement | S006 |
| Product Code | LZS |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |