Excimer Laser System
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION
- PMA Number
- P990027
- Supplement Number
- S006
- 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
- October 10, 2003
- Date Received
- July 18, 2002
- Supplement Type
- Panel Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
- Docket Number
- 03M-0533
Advisory Committee Statement
APPROVAL FOR THE BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION. THE DEVICE USES AN OPTICAL ZONE SIZE BETWEEN 6.0 MM AND 7.0 MM WITH A CONSTANT BLEND ZONE OF .875 MM, AND IS INDICATED FOR WAVEFRONT-GUIDED LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA WITH SPHERE UP TO -7.00 D AND CYLINDER UP TO -3.00 D AND MRSE <=7.50 D AT THE SPECTACLE PLANE; 2) 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; AND 3) IN PATIENTS 21 YEARS OF AGE OR OLDER.
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 |