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 a change in the warning section of the labeling.
| Device | HYPERION LTK SYSTEM |
| Classification Name | Laser, Ophthalmic |
| Generic Name | Laser, Ophthalmic |
| Applicant | SUNRISE TECHNOLOGIES, INC. |
| Date Received | 2000-11-09 |
| Decision Date | 2000-12-11 |
| PMA | P990078 |
| Supplement | S001 |
| Product Code | HQF |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SUNRISE TECHNOLOGIES, INC. 3400 W. Warren Ave. fremont, CA 94538 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990078 | Original Filing | |
| S005 | 2001-08-20 | Normal 180 Day Track |
| S004 | 2000-12-26 | Normal 180 Day Track |
| S003 | ||
| S002 | ||
| S001 | 2000-11-09 | Real-time Process |