FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Excimer Laser System
PMA: P980008
·
Supplement: S009
·
Decision Nov 9, 2001
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
- Supplement Number
- S009
- 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 9, 2001
- Date Received
- October 26, 2001
- Supplement Type
- Special (Immediate Track)
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A CHANGE TO THE QUALITY CONTROL PROCESS THAT WILL EXTEND THE BEAM REPEATABILITY TEST FROM 2 TO 8 HOURS TO MORE ACCURATELY RESEMBLE ACTUAL FIELD USE.
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 |