| 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 | LASERSIGHT LASERSCAN LSX EXCIMER LASER SYSTEM FOR LASER-ASSITED IN SITU KERATOMILEUSIS (LASIK) |
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| Generic Name | Excimer laser system |
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| Applicant | LASERSIGHT TECHNOLOGIES, INC.
6903 UNIVERSITY BLVD.,
WINTER PARK, FL 32792 |
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| PMA Number | P980008 |
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| Supplement Number | S005 |
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| Date Received | 12/19/2000 |
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| Decision Date | 09/28/2001 |
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| Product Code |
LZS |
| Docket Number | 01M-0490 |
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| Notice Date | 10/26/2001 |
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| Advisory Committee |
Ophthalmic |
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| Supplement Type | Panel Track |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
APPROVAL FOR THE LASERSIGHT LASERSCAN LSX EXCIMER LASER SYSTEM FOR LASER-ASSISTED IN SITU KERATOMILEUSIS (LASIK). THE DEVICE IS INDICATED FOR LASIK: 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA RANGING FROM -0.5 TO LESS THAN -6.0 DIOPTERS (D) SPHERICAL EQUIVALENT, WITH ASTIGMATISM LESS THAN OR EQUAL TO 4.5 D, AS MEASURED AT THE SPECTACLE PLANE; 2) IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <= 0.50 D, OR <= 10% OF PREOPERATIVE SPHERICAL EQUIVALENT REFRACTION (SER) SHIFT OVER ONE YEAR PRIOR TO SURGERY; AND, 3) IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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