FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P930016
·
Supplement: S026
·
Decision Nov 3, 2006
Classifications
1
FEI Numbers
9
Registration Numbers
10
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- VISX STAR S4 IR EXCIMER LASER SYSTEM AND WAVESCAN SYSTEM
- PMA Number
- P930016
- Supplement Number
- S026
- 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 3, 2006
- Date Received
- October 24, 2006
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR AN UPGRADE OF THE WAVESCAN SOFTWARE TO VERSION 3.67 TO CORRECT A DESIGN FLAW THAT LED TO AN INCORRECT PATIENT TREATMENT BEING DELIVERED, AND TO INTRODUCE AN ADDITIONAL SOFTWARE CHECK TO MITIGATE TREATMENT CALCULATION ERRORS.
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 |