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 treatment of age-related macular degeneration in patients with predominantly classic subfoveal choroidal neovascularization.
| Device | COHERENT OPAL PHOTOACTIVATOR LASER SYSTEM |
| Classification Name | System, Laser, Photodynamic Therapy |
| Generic Name | System, Laser, Photodynamic Therapy |
| Applicant | LUMENIS |
| Date Received | 1999-08-20 |
| Decision Date | 2000-04-12 |
| Notice Date | 2000-04-12 |
| PMA | P990049 |
| Supplement | S |
| Product Code | MVF |
| Docket Number | 00M-1299 |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | LUMENIS 3959 West 1820 South salt Lake City, UT 84104 |
| Summary: | Summary of Safety and Effectiveness |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990049 | Original Filing | |
| S001 | 2000-08-16 | Normal 180 Day Track |