Excimer Laser System
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- TECHNOLAS 217A EXCIMER LASER SYSTEM
- PMA Number
- P990027
- Supplement Number
- S004
- Device Class
- FDA Class 3
- Product Code
- LZS
- Generic Name
- Excimer laser system
- Medical Specialty
- Unknown
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- February 25, 2003
- Date Received
- December 14, 2001
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
- Docket Number
- 03M-0174
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LZS | Excimer Laser System | FDA class 3 | Unknown |