Excimer Laser System
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
- PMA Number
- P030008
- 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
- March 19, 2003
- Expedited Review
- N
- Docket Number
- 03M-0492
Advisory Committee Statement
APPROVAL FOR THE WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM. THE DEVICES USES OPTICAL ZONES OF 6.0 AND 6.5 MM WITH AN ABLATION/TREATMENT ZONE UP TO 9.0 MM, AND IS INDICATED FOR LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF HYPEROPIC REFRACTIVE ERRORS UP TO +6.0 DIOPTERS (D) OF SPHERE WITH AND WITHOUT ASTIGMATIC REFRACTIVE ERRORS UP TO 5.0 D AT THE SPECTACLE PLANE, WITH A MAXIMUM MANIFEST REFRACTION SPHERICAL EQUIVALENT (MRSE) OF +6.0 D; 2) IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER; AND 3) IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <=0.50 D OF PREOPERATIVE SPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY, EXCLUSIVE OF CHANGES DUE TO UNMASKING LATENT HYPEROPIA.
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 |