Excimer Laser System
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- LADARVISION 4000 EXCIMER LASER SYSTEM
- PMA Number
- P970043
- Supplement Number
- S020
- 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
- May 1, 2006
- Date Received
- May 27, 2005
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
- Docket Number
- 06M-0323
Advisory Committee Statement
APPROVAL FOR THE LADARVISION 4000 EXCIMER LASER SYSTEM AND THE LADAR 6000 EXCIMER LASER SYSTEM. THESE DEVICES USE A 6.5 MM OPTICAL ZONE AND A 9.0 TREATMENT ZONE AND ARE INDICATED FOR WAVE-FRONT GUIDED CUSTOMCORNEA LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF HYPEROPIA AND HYPEROPIC ASTIGMATISM OF +0.75 D TO LESS THAT +5.00 D OF SPHERE WITH UP TO -3.00 D OF CYLINDER (WHICH HAS A MAGNITUDE LESS THAN OR EQUAL TO THE SPHERE IN MINUS CYLINDER CONVENTION) AND UP TO +5.00 CYCLOPLEGIC SPHERICAL EQUIVALENT AT THE SPECTACLE PLANE; 2) IN PATIENTS 21 YEARS OF AGE OR OLDER; AND 3) IN PATIENTS WITH DOCUMENTED STABILITY OF REFRACTION FOR THE PRIOR 12 MONTHS, AS DEMONSTRATED BY A CHANGE IN SPHERE AND CYLINDER OF LESS THAN OR EQUAL TO 0.50 D.
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 |