Excimer Laser System
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
- PMA Number
- P020050
- Supplement Number
- S012
- 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
- September 27, 2013
- Date Received
- April 1, 2013
- Supplement Type
- Panel Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
- Docket Number
- 13M-1321
Advisory Committee Statement
APPROVAL FOR THE ALLEGRETTO WAVE® EYE-Q 400HZ EXCIMER LASER SYSTEM. THIS DEVICE IS INDICATED FOR THE FOLLOWING: THE WAVELIGHT ALLEGRETTO WAVE® EYE-Q EXCIMER LASER SYSTEM USED IN CONJUNCTION WITH THE WAVELIGHT ALLEGRO TOPOLYZER (TOPOGRAPHER) AND T-CAT TREATMENT PLANNING SOFTWARE IS INDICATED FOR PERFORMING TOPOGRAPHY-GUIDED LASER ASSISTED IN SITU KERATOMILEUSIS (TOPO-GUIDED (T-CAT) LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF UP TO -9.00 DIOPTERS (D) OF SPHERICAL EQUIVALENT MYOPIA OR MYOPIA WITH ASTIGMATISM, WITH UP TO -8.00 D OF SPHERICAL COMPONENT AND UP TO -3.00D OF ASTIGMATIC COMPONENT AT THE SPECTACLE PLANE; 2) IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER; AND 3) IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS 0.50D OR LESS OF PREOPERATIVE SPHERICAL EQUIVALENT 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 |