Excimer Laser System
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- VISX EXCIMER LASER SYSTEM MODELS B AND C
- PMA Number
- P930016
- 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
- January 29, 1998
- Date Received
- July 23, 1997
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- Y
- Docket Number
- 99M-0293
Advisory Committee Statement
Approval for the VISX Excimer Laser System (Models B and C). This device is indicated for myopic and astigmatic PRK using an ablation zone with a 6.0 mm major axis. The PRK procedure is intended for use: 1)in patients with documented evidence of a change in manifest refraction of less than or equal to 0.5D (in both cylinder and sphere components) per year for at least one year prior to the date of the pre-operative examination; and 2) in patients 18-20 years of age in PRK treatments for the reduction or elimination of myopia (nearsightedness) of less than or equal to -6.0 D spherical equivelent at the corneal plane with less than or equal to -1.0 D of astigmatism; or 3) in patients 21 years of age or older in PRK treatments for the reduction or elimination of myopia (nearsightedness) of between 0 and -12.0 D spherical myopia at the spectacle plane and up to -4.0 D of astigmatism.
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 |