FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P910062
·
Decision Sep 29, 1995
Classifications
1
FEI Numbers
9
Registration Numbers
10
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- VISX MODELB/MODEL C EXCIMER LASER SYSTEM
- PMA Number
- P910062
- 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 29, 1995
- Date Received
- October 16, 1991
- Expedited Review
- N
- Docket Number
- 96M-0486
Advisory Committee Statement
APPROVAL FOR VISX EXCIMER LASER SYSTEM (MODELS B & C)
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 |