Excimer Laser System
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- LADARVISION 4000 EXCIMER LASER SYSTEM
- PMA Number
- P970043
- Supplement Number
- S015
- 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
- June 29, 2004
- Date Received
- September 30, 2003
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
- Docket Number
- 04M-0312
Advisory Committee Statement
APPROVAL FOR THE LADARVISION 4000 EXCIMER LASER SYSTEM. THE DEVICE USES A 6.5 MM OPTICAL ZONE, A 9.00 MM ABLATION ZONE, IS LOCKED-OUT FOR TREATMENTS ABOVE -9.75 DIOPTERS (D) SPHERE, -5.00D CYLINDER, AND -10.63D SPHERICAL EQUIVALENT (SE), AND IS INDICATED FOR WAVEFRONT-GUIDED LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIC ASTIGMATISM UP TO -8.00D SPHERE WITH -0.50 TO -4.00D CYLINDER AND UP TO -8.00D SE AT THE SPECTACLE PLANE; 2) IN PATIENTS WHO ARE 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 0.50D FOR A SE OF UP TO -6.00D AND LESS THAN OR EQUAL TO 0.75D FOR A SE GREATER THAN -6.00D.
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 |