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 sunrise hyperion(tm) ltk system. The device is indicated for temporary reduction of hyperopia in patients with +0. 75 to +2. 5 diopters of manifest refraction sphericla equivalent (mrse) at the spectacle plane (with cylinder less than or equal to +-0. 75 diopters) who are 40 years of age or older with documented stability of refraction for the prior 6 months, as demonstrated by a change of less than or equal to 0. 50d in spherical, and cylindrical components of the manifest refracs
| Device | HYPERION LTK SYSTEM |
| Classification Name | Laser, Neodymium:yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary |
| Generic Name | Laser, Neodymium:yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary |
| Applicant | SUNRISE TECHNOLOGIES, INC. |
| Date Received | 1999-11-03 |
| Decision Date | 2000-06-30 |
| Notice Date | 2000-07-11 |
| PMA | P990078 |
| Supplement | S |
| Product Code | LOI |
| Docket Number | 00M-1386 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SUNRISE TECHNOLOGIES, INC. 3400 W. Warren Ave. fremont, CA 94538 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| 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 |