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 visx excimer laser system model c (star s2) which included the right to reference information contained in p930016 from visx, inc. , of santa clara, ca. This device is indicated to perfrom lasik: 1) in patients 18 years of age or older in treatments for the reduction or elimination of myopia (nearsightedness) from 0 to -14. 0 diopters (d) with or without -0. 5 d to -5. 0 d of astigmatism; and 2) in patients with documented evidence of a change in manifest refraction of less than or equalto 0. 5 d (in both cylinder and sphere components) per year for at least one year prior to the date of pre-operative examination.
| Device | VISX EXCIMER LASER SYSTEM MODEL C STAR |
| Classification Name | Excimer Laser System |
| Generic Name | Excimer Laser System |
| Applicant | AMO Manufacturing USA, LLC |
| Date Received | 1999-02-23 |
| Decision Date | 1999-11-19 |
| Notice Date | 2000-08-18 |
| PMA | P990010 |
| Supplement | S |
| Product Code | LZS |
| Docket Number | 00M-1447 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | AMO Manufacturing USA, LLC 510 Cottonwood Drive milpitas, CA 95035 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990010 | Original Filing | |
| S008 | 2018-12-31 | Real-time Process |
| S007 | 2014-07-07 | Real-time Process |
| S006 | 2014-05-19 | 30-day Notice |
| S005 | ||
| S004 | 2014-05-01 | 30-day Notice |
| S003 | ||
| S002 | ||
| S001 | 2000-04-12 | Real-time Process |