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.
| Device | PHOTOTOME(TM) SYSTEM 2700 |
| Generic Name | Laser, Neodymium:yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary |
| Applicant | LASER MEDIA |
| Date Received | 1985-03-28 |
| Decision Date | 1985-08-08 |
| Notice Date | 1985-09-18 |
| PMA | P850019 |
| Supplement | S |
| Product Code | LOI |
| Docket Number | 85M-0391 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | LASER MEDIA 77 Arkay Dr. hauppauge, NY 11788 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850019 | Original Filing | |
| S002 | 1986-09-08 | Normal 180 Day Track |
| S001 | 1985-10-28 |