Excimer Laser System
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- WAVELIGHT ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
- PMA Number
- P020050
- Supplement Number
- S005
- 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
- April 9, 2007
- Date Received
- December 19, 2006
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A CHANGE IN THE REPETITION RATE FROM 200 HZ TO 400 HZ. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM AND IS INDICATED FOR LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) FOR: 1) THE REDUCTION OR ELIMINATION OF NATURALLY OCCURRING MIXED ASTIGMATISM OF UP TO 6.00 DIOPTERS (D) AT THE SPECTACLE PLANE IN PATIENTS WHO ARE 21 YEARS OF AGE OR OLDER WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <=0.50 D OF PREOPERATIVE SPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY; AND 2) THE WAVEFRONT-GUIDED (WFG) REDUCTION OR ELIMINATION OF UP TO -7.00 DIOPTERS (D) OF SPHERICAL EQUIVALENT MYOPIA OR MYOPIA WITH ASTIGMATISM, WITH UP TO -7.00 D OF SPHERICAL COMPONENT AND UP TO 3.00 D OF ASTIGMATIC COMPONENT AT THE SPECTACLE PLANE IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <=0.50 D OF PREOPERATIVE SPHERICAL SHIFT OVER ONE YEAR PRIOR TO SURGERY.
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 |