FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P930016
·
Supplement: S028
·
Decision Apr 9, 2008
Classifications
1
FEI Numbers
9
Registration Numbers
10
Basic Information
- Device Name
- Excimer Laser System
- Trade Name
- STAT S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM
- PMA Number
- P930016
- Supplement Number
- S028
- 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
- April 9, 2008
- Date Received
- October 29, 2007
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR AN ALTERNATE MANUFACTURING SITE LOCATED AT AMP MANUFACTURING USA, LLC, MILPITAS, CALIFORNIA.
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 |