FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P980008
·
Decision Nov 12, 1999
Classifications
1
FEI Numbers
9
Registration Numbers
10
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- LASERSCAN LSX EXCIMER LASER SYSTEM
- PMA Number
- P980008
- 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
- November 12, 1999
- Date Received
- March 19, 1998
- Expedited Review
- N
- Docket Number
- 00M-1231
Advisory Committee Statement
Approval for the LaserScan LSX Excimer Laser System. The device is indicated for myopic photorefractive keratectomy: for the reduction or elimination of myopia ranging from -1.0 to less than -6.0 diopters (D) with less than or equal to 1.0 D of astigmatism; in patients with documentation of a stable manifest refraction (+-0.5D) over the prior one year; and in patients who are 18 years of age or older.
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 |