Note: 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. |
|
Device | SUNRISE TECHNOLOGIES HYPERION(TM) HOLMIUM LASER SYSTEM FOR LASER THERMAL KERATOPLASTY (LTK) |
Generic Name | Laser, ophthalmic |
Regulation Number | 886.4390 |
Applicant | SUNRISE TECHNOLOGIES, INC. 3400 W. WARREN AVE. FREMONT, CA 94538 |
PMA Number | P990078 |
Supplement Number | S004 |
Date Received | 12/26/2000 |
Decision Date | 03/16/2001 |
Product Code |
HQF |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A SOFTWARE MODIFICATION TO THE EYE TRACKER. |
|
|