Excimer Laser System
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- MEDITEC MEL 80 EXCIMER LASER SYSTEM
- PMA Number
- P060004
- Supplement Number
- S001
- 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
- March 28, 2011
- Date Received
- December 28, 2007
- Supplement Type
- Panel Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
- Docket Number
- 11M-0256
Advisory Committee Statement
APPROVAL FOR THE MEL 80 EXCIMER LASER SYSTEM. THIS DEVICE USES AN OPTICAL ZONE OF 6.0 TO 6.5 MM IN DIAMETER AND A TRANSITION ZONE OF 2.0 TO 4.0 MM FOR A TOTAL ABLATION DIAMETER OF 10.0 MM, AND IS INDICATED FOR PRIMARY LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) TREATMENTS FOR: 1) THE REDUCTION OR ELIMINATION OF NATURALLY-OCCURRING HYPEROPIA OF LESS THAN OR EQUAL TO +5.0 D WITH OR WITHOUT REFRACTIVE ASTIGMATISM OF > +0.5 AND <= +3.0D, WITH A MAXIMUM MRSE OF +5.0D; 2) IN PATIENTS WHO ARE 21 YEARS OF AGE OR OLDER; AND 3) WITH DOCUMENTATION OF STABLE MANIFEST REFRACTION OVER THE PAST YEAR AS DEMONSTRATED BY CHANGE IN SPHERE AND CYLINDER OF <= 0.5D.
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 |