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 | LASER SCAN LSX EXCIMER LASER |
Generic Name | Excimer laser system |
Applicant | LASERSIGHT TECHNOLOGIES, INC. 6903 UNIVERSITY BLVD., WINTER PARK, FL 32792 |
PMA Number | P980008 |
Supplement Number | S003 |
Date Received | 07/20/2000 |
Decision Date | 08/15/2000 |
Product Code |
LZS |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN THE LASER PULSE REPETITION RATE FROM 100 TO 200 HZ. |
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