Premarket Approval (PMA)

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: 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