Excimer Laser System
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- LADARVISION EXCIMER LASER SYSTEM
- PMA Number
- P970043
- Device Class
- FDA Class 3
- Product Code
- LZS
- Generic Name
- Excimer laser system
- Medical Specialty
- Unknown
- Advisory Committee
- Ophthalmic
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- November 2, 1998
- Date Received
- September 5, 1997
- Expedited Review
- N
- Docket Number
- 00M-1592
Advisory Committee Statement
Indicated for use in photorefractive keratectomy (PRK) treatment for the reduction or elimination of mild to moderate myopia in patients with the following three characteristics: 1) between -1.00D to -10.00D of sphere and less than or equal to -4.00D of astigmatism at the spectacle plane, the combination of which must result in an attempted correction between -0.50D and -10.00D spherical equivalent (SE) at the spectacle plane where sphere or cylinder is at least 1.00D; 2) who are 21 years of age or older; and 3) with documented stability of refraction for the prior 12 months, as demonstrated by a change of less than or equal to 0.50D for corrections up to -7.00D SE, and less than or equal to -1.00D for corrections greater than -7.00 D SE.
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 |