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 nidek ec-5000 excimer laser system. The device uses a 6. 0 mm optical zone and a 9. 0 mm treatment zone and is indicated for laser assisted in-situ keratomileusis (lasik): 1) for the reduction or elimination of hyperopia refractive errors from +0. 5 to +5. 0 d of sphere with or without astigmatic refractive errors from +0. 5 to +2. 0 d at the spectacle plane with manifest refraction spherical equivalent (mrse) of +5. 0 d or less; 2) in patients 21 years of age or older; and 3) in patients with documented stability of manifest refraction over the prior year, demonstrated by a change in mrse not greater than +/- 0. 50 diopter.
| Device | NIDEK EC-5000 EXCIMER LASER SYSTEM |
| Classification Name | Excimer Laser System |
| Generic Name | Excimer Laser System |
| Applicant | NIDEK CO., LTD. |
| Date Received | 2005-11-23 |
| Decision Date | 2006-10-11 |
| Notice Date | 2006-11-14 |
| PMA | P970053 |
| Supplement | S009 |
| Product Code | LZS |
| Docket Number | 06M-0460 |
| Advisory Committee | Ophthalmic |
| Supplement Type | Panel 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 |
| 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 |