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Device | TECHNOLAS 217A EXCIMER LASER SYSTEM |
Generic Name | Excimer laser system |
Applicant | TECHNOLAS PERFECT VISION GMBH MESSERSCHMITTSTR 1 + 3 MUNCHEN 80992 |
PMA Number | P990027 |
Supplement Number | S004 |
Date Received | 12/14/2001 |
Decision Date | 02/25/2003 |
Product Code |
LZS |
Docket Number | 03M-0174 |
Notice Date | 04/28/2003 |
Advisory Committee |
Ophthalmic |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE TECHNOLAS 217A EXCIMER LASER SYSTEM. THE DEVICE USES AN OPTICAL ZONE TREATMENT RANGE FROM 5.00 MM TO 6.00 MM WITH A BLEND ZONE OF 1.90 MM FOR SPHERICAL HYPEROPIA AND 1.75 MM FOR HYPEROPIC ASTIGMATISM. THE LASER IS LOCKED OUT FOR REFRACTIVE CORRECTIONS GREATER THAN +4.00 D SPHERE AND GREATER THAN +2.00 D CYLINDER. THE DEVICE IS INDICATED FOR LASER IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS: 1) FOR THE REDUCTION OR ELIMINATION OF LOW-TO-MODERATE NATURALLY OCCURRING HYPEROPIA UP TO +4.00 DIOPTERS (D) MRSE, WITH SPHERE BETWEEN +1.00 TO +4,00 D WITH OR WITHOUT REFRACTIVE ASTIGMATISM UP TO +2.00 D AT THE SPECTACLE PLANE; 2) IN PATIENTS WHO ARE 21 YEARS OF AGE OR OLDER; AND, 3) IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF LESS THAN OR EQUAL TO 0.50 DIOPTERS (IN BOTH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF THE PRE-OPERATIVE EXAMINATION. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |