FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P930016
·
Supplement: S046
·
Decision Jan 11, 2016
Classifications
1
FEI Numbers
9
Registration Numbers
10
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- STAR EXCIMER LASER SYSTEM
- PMA Number
- P930016
- Supplement Number
- S046
- 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 11, 2016
- Date Received
- October 19, 2015
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR CHANGES TO THE FRONT PANEL ASSEMBLY OF THE STAR S4 IR SYSTEM WITH RELATED CHANGES AND MINOR UPDATES TO THE STAR S4 IR OPERATORS MANUAL.
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 |