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. |
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Device | HYPERION LTK SYSTEM |
Generic Name | Laser, ophthalmic |
Regulation Number | 886.4390 |
Applicant | SUNRISE TECHNOLOGIES, INC. 3400 W. WARREN AVE. FREMONT, CA 94538 |
PMA Number | P990078 |
Supplement Number | S001 |
Date Received | 11/09/2000 |
Decision Date | 12/11/2000 |
Product Code |
HQF |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN THE WARNING SECTION OF THE LABELING. |
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